Ceci n’est pas une période de transition and first reaction to the Implant Files

This is not the transitional period you are looking forAs we are just past the halfway point of the MDR transitional period for the MDR and are well into the one for the IVDR there is one thing that has become very very clear:  the transitional period in the MDR and likely the one in the IVDR is not actually a transitional period for industry and certainly not the one you are looking for. It is more like an extended implementation period for the authorities to complete the regulations that came out of the legislative procedure as finished regulations but as a half-baked regulatory system that required a lot of additional implementation for it to be functional.

As reported in previous blogs, the implementation machine at EU level (which is mostly a concerted effort by national authorities that have a difficult time agreeing on the details of implementation of the CAMD Roadmap). We were initially happy with the prioritization of items in the roadmap, until they unfortunately turned out to be aspirational rather than committal.

Rolling plan

The European Commission has now released a working plan for the remainder of the transitional period, the “rolling plan” with expected timelines and next steps for implementation of items from the MDR – unfortunately also rather non committal.

As you can see in the rolling plan document, most of the things will happen Q4 2019 / Q1 2020, in other words: critical implementation mass at the end of the transitional period. This is an issue for manufacturers seeking to implement the MDR and IVDR, because this means that although the framework of the MDR and IVDR was ready by May 2017, with most of the sometimes very critical details to prepare for to come much later, leaving essentially no meaningful implementation period for industry.

The implementation period is effectively used by the authorities for their own roll-out of the system, rather than to provide industry with a meaningful period to transition each and every device on the EU market to the new system, which is already a Herculian effort with a full three years available.

Eudamed and Single Registration Numbers

A poignant example are the Eudamed Single Registration Number (SRN) process and interfacing specifications (not even starting about Eudamed’s ready for use date as such).  SRNs are the only thing that the EU does not provide – you have to get them on a national level and the member states have to set up mechanisms for issuing them after verification of the identity of the manufacturer, authorised representative or importer.

If you are a company with many products, you need to be able to talk to Eudamed on a machine to machine basis as soon as Eudamed goes online. Without an SRN however it seems you cannot interact with the Eudamed database, which will be necessary when Eudamed becomes applicable.

Have you checked with the competent authority in the member state where you are as manufacturer or where your authorized representative is when they will have an SRN for you and what you need to do for that? 

CS for non-devices

Another one is the common specificiations for non-medical devices: arriving November 2019 while you should be compliant by 26 May 2020. That’s a cool six months to re-invent a product that is not a medical device as a medical device and really not a meaningful transitional period. Good luck with that!

Harmonised standards

And how about the harmonised standards for the MDR/IVDR? Anyone? The regulatory system under the directives was built on the assumption of conformity with the directives if you conformed to a harmonized standard. We are carrying over this system into the MDR and IVDR so these harmonised standards are kind of important if you want to declare or assess conformity with the general safety and performance requirements under the MDR and IVDR and rely on the presumption of conformity that meeting a harmonised standard affords as COCIR points out quite rightly.

 As the rolling plan says: consultation of the member states on the scope of the first mandate is ongoing; expect a decision by Q1 2019. Wait what – first mandate? So there will be more? Yes, apparently we have quite a number of harmonised standards under the current directives, so it looks like the EU will harmonise standards under the MDR in tranches. When what why how? Your guess is as good as mine. I’ve heard that the plan is to start with the most important horizontal standards first. Which are? Surprise! Your guess is as good as mine.

Where is the European Parliament?

Yet, the Commission is playing ‘nice weather’/’these are not the droids you are looking for’ also in European Parliament by saying that everything is on track and that there is nothing to get all excited about. Well, I suppose you could say that even a burning runaway train that is going to arrive late and blow up the station is ‘on track’ in a sense of the literal meaning of the words.

Because where is our fiery European Parliament in all of this? It was so totally prepared during the legislative procedure to call industry by the worst of names (“single use labelling is like printing your own money“, remember?). There will be at least some notified bodies in time – sure, but will they have even close to the capacity requirements to deal with the workload coming their way (see below for more about that)? These are the important questions. An incomplete and under-resourced system is not going to deliver and a failed system is not a successful system. Our guardian of the citizens and its ENVI committee with an opinion about everything devices related seems to be comfortably sitting on its hands watching the European implementation machine fail to deliver a complete regulatory system timely.

The European Parliament will probably blame someone else because they had to make so many compromises to have the rules adopted in the first place. This is seems to be the approach that Ms Roth-Behrend (the wings are on fire again) seems to be saying the media push started by the ICIJ’s Implant Files: blame everybody but us. How convenient. But how about maybe taking some responsibility now? 

Joint assessment process of notified bodies

The Commission also published an update of the joint assessment process of notified bodies. This nothing to become enthusiastic about, even though the Commission tried to put a positive spin on this in European Parliament by saying that more than half of the currently notified notified bodies have applied. Hurray! Does that mean that the capacity the market requires for transition all CE certificates on the market to the new system will be online timely?

Probably not: so far only 6 notified bodies have handed in CAPA plans (which likely means that all of the other applications have not made it to that level because as far as I know no notified body sailed through the joint assessments without CAPAs), only one final JAT opinion was issued for a lucky notified body that might be notified in Q1 2019 (provided that the final designating authority report is also issued) and no final designating authorities reports (which marks the ‘internal’ end of the designation process) have been issued. This means that in the most optimistic scenario notifications will start to trickle in one by one from somewhere in Q1 2019. It’s like I tell my kids over and over again: your homework is not finished until it’s done. And this stuff is so way not done yet.

Let’s take a realistic view at capacity coming online and capacity needed as Medtech Europe has been doing. It is becoming very clear now that several factors are brewing to create a perfect storm of undercapacity of the system as explained in the below MedTech Europe infographic:

  • more and more notified bodies are closing down or not applying for MDR/IVDR notification;
  • the Brexit is coming up with ~ 40% of the EU notified body capacity in the UK at risk (although this problem is temporarily delayed now – see below);
  • fewer and fewer notified bodies do more of the work.

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It’s not an exaggeration, this notified body capacity issue. In addition, notified bodies are increasing getting in worse shape, likely resulting from the pressure on their organization to get more work done than they can manage in parallel to the time consuming MDR and/or IVDR accreditation application.

Every week almost I am being contacted by desperate companies that run into catastrophic issues with their notified bodies (mainly the smaller ones), such as:

  • certificate expiry because the notified body is unable to schedule and/or complete a timely recertification audit and often does not stick to agreed dates or promised actions, combined on occasion with the ‘solution’ that the deadline may be met if the client pays a considerably higher fee (I’ve seen twice normal rate);
  • notified bodies flat out denying having received documentation as an excuse for missing auditing slots so they can skip the audit;
  •  notified bodies letting a certificate expire in a certificate in one of the above scenario and rather than taking remedial action charging the company for a full renewed entrance audit for the device and taking a very long time for that;
  • suspending a certificate for all devices of the company while the intention was to suspend it only partially for one and then take weeks to reinstate the certificate;
  • etc.

I think authorities can be a lot more sensitive to these kinds of things, regardless of whether they are caused by bad faith or negligence, or just by under-capacity, because manufacturers just have no meaningful legal recourse against a misbehaving or blundering notified body. Requesting specific performance under the certification agreement in court almost never works in practice, and internal dispute resolution mechanisms of the notified body will usually find that the notified body is right and take a long time. 

So far I’ve found only one competent authority interested to hear about these things and willing to do something. Others are very standoffish or see it as commercial problem. That, I think, is way too easy if you’re finally responsible for the notified body’s good administration practices as notifying member state. Let’s not forget that the notified bodies are exercising delegated state authority. It would be very nice if the member states responsible would act like they are supervising their own institutions.

These notified body issues will only get worse as we get closer to the date of application of the MDR more notified bodies will keel over or start to exhibit this kind of behavior. Once we’re past the date of application this will really become a problem because then manufacturers cannot change notified body anymore. As long as they do not yet have their first CE certificate, it is unsure whether the MDR regime for delisted notified bodies in article 46 MDR applies and you can imagine how this will impact manufacturers that go for soft transition and then lose their notified body (and, as a consequence, their certificate).

Brexit

It seems that we have white smoke on the Brexit, but don’t get your hopes up yet. Whatever has been agreed (we still don’t know exactly) has to be ratified by a bunch of parliaments. Especially the Brexiteers in the UK parliament could seriously rain on this party.

But suppose the Brexit gets ratified. And then we have a transitional regime that lasts until 31 December 2020 – right in the soft transition period. And no certainty what comes next because that still needs to be agreed during the transitional period.

Implant Files

Then there are the Implant Files, a pretty large investigative journalism project aimed to hammer home the message that we have been hearing for years: CE marking sucks, notified bodies are evil corporations with a built in conflict of interest and government and industry are evil too, covering up piles of unnecessary cases of death and harm caused by faulty medical technology. Sounds dramatic, right? Because that’s news – no drama, no news that people are interested in.

But in my view this is no news at all – in fact this is all very much after the fact. We knew that the EU system could be improved, and that’s what’s happening with the new regulations. We also knew that vigilance reporting could be more transparent, which is why Eudamed is set up and will be much more transparent.

So here is my first reaction – since I’ve been quoted and have spoken to several journalists involved in multiple unsuccessful attempts to explain EU medical devices regulation to them, I feel I am entitled to an opinion in this matter. After all, journalists call me the manufacturers’ darling so I may have something to contribute to the discussion. For full disclosure: keep in mind that this is exactly what I am – manufacturers are my clients and I never make a secret of this so people know where I come from. I do not work for patients. So, believe what you will about facts but I do know the rules.

I think this initiative does underline that it is important what the changes in EU law with the new MDR and IVDR are going to do already: make more information about devices available to the public, such as by means of the Eudamed database that will contain a lot of extra information about devices. This is a good thing and yes, it could have been done earlier, but now it is at least happening. 

However, I think the conspiracy theory assumption underlying many of the publications that this information is deliberately withheld is not productive, because this conspiracy does not exist in my experience. But these days you need a good conspiracy theory to have a good story so how do you create a conspiracy theory? The reporters tried to obtain massive amounts of vigilance reports relating to implants by use of freedom of information requests, because there is no EU law and (that I’m aware of) national law in the EU that allows for access to vigilance data held by authorities. However, vigilance reports are full of confidential technical information of companies about how a device works and sensitive personal data of patients and doctors that you cannot just make public like that. Freedom of information laws have protections built in to protect these interests. It would be kind of strange that anyone (anyone) can just petition authorities for documents containing technical information provided in confidence or personal data concerning health of patients, right? That’s however what they did, and then they were very angry that they did not get all the information they wanted immediately and without redactions in accordance with the law. Only one conclusion possible: it must be a conspiracy! I think that is somewhat disingenuous and frankly quite naive. But it’s good drama, so good news to sell.

I have read most of the German, Dutch, UK, French and Belgian publications that have come out so far and they paint a picture of evil government and evil industry withholding information and making bad devices that fail more often than they should. Nothing new so far – haters are going to hate no matter what and news without drama will not sell. I think that in reality the picture is far more nuanced than presented that but that would not be news of course. CE marking is not a perfect system, but no regulatory system is perfect.

In fact, if you look at how the other regulatory systems for devices perform in the world, they perform no better than the CE marking system. The articles leave out a lot of things that would make them more balanced, like the fact that notified bodies are overseen and accredited by national authorities and that the authorities do diligently follow up every vigilance report that they receive.

A positive development of the Implant Files is more attention for regulation of medical devices, and specifically for resources committed by authorities. The CE marking system has so far performed very well with very little resources committed to it. This is a political choice that all of us are making together, see also what I wrote above here in this post. But it needs to be resourced properly for it to work. Look at the system for medicines: this is resourced much much better than the devices system and lo and behold, it’s the example for other systems. No shit Sherlock, you get what you pay for – also when it comes to regulatory systems. Also this is being addressed in the MDR and IVDR, by the way, with a renewed vigilance and market surveillance system. Now we just need some resources to roll out the system timely, as discussed above.

The Implant Files articles point at an increase of incidents in total, but they do not place it in the wider context of the increased use of implants for example, which is a missed opportunity to make it less sensationalist and more balanced. Oh wait – less sensation was not the point. Similarly, the assumption underlying the reporting seems to be that any incident in a treatment involving a device is attributable to the device only, while this if of course not necessarily true. Doctors may choose a perfect device for the wrong reasons, as a result of which the treatment will not deliver the results aimed for and the device is blamed. Or, what I often see in my practice: the device may fail as a result of the doctor’s fault. These cases are reported as incidents but are not attributable to the device, even if the device is a causal link in the damage.

It would also have been interesting if they would have compared medicines side effects to medical devices side effects so you can actually say something about acceptability of level of side effects. Medicines, their side effects and medication errors kill loads of people every year. Yet, I don’t hear people advocate for autopsy on every person taking meds that dies outside the hospital, even though enormous amounts of people die from adverse reactions to prescription medicines. Yet, this was proposed in one of the Implant Files items for people with pacemakers / ICDs.

Medicines have more robust trails because they take forever and have lots of people in them, and they have arms, including a placebo arm! But the nuance is again lost there too: you have to test a medicine in a clinical trial delivering results based on statistics because we do not fundamentally fully comprehend human biochemistry and make it transparent, so it’s actually a very crude mechanism. It’s like throwing someone out of an airplane to test a parachute. Maybe a lot of people, so it’s statistically sound. And then we throw some people out without parachute but tell them that we’re not sure if they have one or not to correct for the placebo effect. That is – conceptually – how we test medicines for a lack of better methods.

And did you know by the way that regardless of all that rigorous testing medicines remain incredibly dangerous and kill loads of people? The European Commission estimates that adverse reactions from prescription drugs cause 200,000 deaths per year in the EU, making prescription medicines drugs a major health risk, ranking 4th with stroke as a leading cause of death. Maybe not the best product to compare medical devices too, because I bet medical devices are not the 4th highest cause of death, not even by the estimation of the Implant Files. Would we like an approval mechanism that makes medical devices just as much of a universal killer as medicines? I bet we don’t. That is why these comparisons are so meaningless. 

With devices however you can usually test if the device works or not because they work physically and not systemically, so you need fewer patients and less statistics. It would be quite immoral too to implant people with placebo pacemakers or placebo hips to see if the pacemaker or hip actually works. Because that is how we test medicines statistically for lack of a better way: you cannot observe biochemistry in action the way you can observe and test devices that act physically. It’s that simple, and that’s why we do not need huge populations of trial subjects to arrive at statistically relevant conclusions about how biochemistry functioned and what effects it had. That is why it makes a lot of sense to test medical devices clinically against the standard of care to see if they improve care compared to available solutions and check for unpredicted side effects, but a trail to statistically figure out if they work in the first place is not that ethical mostly.

You can wonder whether some implantable devices based on what companies thought was well understood technology were followed up with patients long enough because they did lead to systemic issues – and we did. It’s why we are experimenting with increased post market clinical follow up requirements under the current rules already, are fixing this too in the MDR and are paying particular attention to new implants, which need more data in advance. The Implant Files are conveniently ignoring that the EU started a major program to improve quality of approval, oversight and clinical evidence for medical devices in 2012 and has been rolling that out ever since, culminating in the new Medical Devices Regulation that entered into force last year and will apply in all aspects soon. But a problem solved is of course no news, so that is why the efforts to improve legislation that has been going on for years is basically not mentioned in the Implant Files.  

Another problem I have with the Implant Files is how the articles and the TV shows blend US and EU requirements as if they are one single thing and draw implicit conclusions from this weird blend for the EU state of affairs. For example, a US expert is interviewed  about how you can misrepresent things on an FDA incident reporting form in the US by selectively ticking boxes concerning cause of death and it is implied that the same is possible and in fact happens in the EU. However, as a starting point the EU model form for incident reporting is structured very differently, and this is not even addressed, nor how you would use that form to manipulate your vigilance reporting. Yet, the message is that this happens in the EU as well. There is no evidence however in the reporting that I came across of how you would do this in the EU. This is strange because the FOI requests provided the journalists with a deluge of EU vigilance reports and forms, which they could have easily checked. But they didn’t. This is just an example of one of the many things that give a wrong impression and I think unduly so.

The above is just a first impression. I will write more about the Implant Files, if only to help correct the sensationalist picture created on often half baked understanding or representation of the EU regulatory system.

MDR/IVDR Implementation: the transition period halfway point

Naminbia roadIf you are still free this Wednesday afternoon and somehow involved on the medical devices industry in the EU, our seminar that afternoon in Amsterdam is for you as it discusses where we are with the implementation of the MDR and IVDR. We still have a few seats available, so this will be time well spent. Regardless of many requests we are not streaming or recording the seminar – we prefer the face to face contact. The presentations will be available on my firm’s website though.

Your time will be especially well spent because of the excellent speaker line-up:

  • Gert Bos from Qserve on how to work with your notified body;
  • Anja Wiersma from Mi-CE on what clinical, scientific and analytical evidence you will need for medical devices and IVDs and how to generate it timely;
  • Erik Raadsheer from Align Technologies on how a medical devices company implements the MDR in a practical way; and
  • myself about where we are with the regulations, implementation, Brexit etc.

The focus of the seminar is not on what the MDR and IVDR require in general (you should be well aware of that by now) but rather on where a company in medical devices and IVDs should be by now with its implementation work. The seminar will integrate the latest state of affairs with dependencies as e.g. Brexit as per the date of today.

Where should you be?

Not sitting on your hands, as I’ve been saying for a long time. I was moderating the EU MDR panel at Advamed’s MedTech Conference in Philadelphia on 24 September with so far the most mixed and complete panel so far with two competent authorities, a ministry of health, a notified body, an international devices company, a consulting company and MedTech Europe. It was a very good session with a lot of good information from the authorities.

It took place on a date nearly six years after the first draft of the MDR and IVDR were published and on the date that the MDCG had a meeting in Brussels to discuss progress of rolling out of these regulations. One of the pressing points is where the roll-out is and whether the regulatory system will be able to deliver on the daunting task of having to transition all medical devices and IVDs currently on the EU market to the new system in a shrinking amount of time with many parts of the regulatory system still unclear or up in the air. The big known unknown is if the notified body capacity that will at some point will become available to market gradually will be able to guarantee a transition that nobody anymore expects to be smooth – everyone will be happy if it is not too messy.

The shrinking time left until the Date of Application for the MDR (26 May 2020) has caused widespread hope and wishful thinking that the dates of application will be moved or that there will be other changes to manage the bottleneck expected towards the date of application. While industry is advocating a change of the implementation deadlines with the Commission and the member states because of the limited notified body capacity and the limited roll-out of implementation items and has put this on the agenda at the 24 September MDCG meeting, be very very warned that this is by no means certain to happen.

The panel gave a unitary message: no matter the degree of uncertainty about notified bodies and dates of application, your very worst option as manufacturer at the moment is to do nothing. If you are only starting the transition work now, you may be too late already, unless you have very few products in your company.

The panel also showed how the complexity of the EU CE system works against it at this moment:

  • The competent authorities drafted the CAMD Roadmap but the implementation is left to the new committees under the MDCG that are replacing the current medical devices expert groups (MDEGs) and the authorities cannot make these committees deliver the documents and guidance in time. This is problematic because for example the work on the clinical guidance in the relevant group seems to have broken down for the moment.
  • The ministries of health have delivered with the MDR and IVDR texts and for them there is not much to do, except focus on national implementation of the policy discretion that the regulations allow. We will take a first look at the Dutch implementation act at the seminar. Their message: work with what is there and you’ll be able to do most of the work. Notified bodies have to apply, and the applications must be good enough. They have provided and staffed an approval system for the notified bodies, but now the notified bodies are finding it more difficult than expected to meet the requirements for being a notified body under the new regulations, which especially affects the smaller notified bodies with a large scope. The first applicant notified body has in the mean time dropped out, having decided to put its money on consulting rather than being a notified body.
  • Companies are getting exasperated because they require certainty for the rather considerable investments that they must make in the new system, while the system is still unfinished in several crucial aspects (like Eudamed and the essential implementing acts). They will happily so it generally because they are convinced that the new rules are in fact an improvement. However, it cannot be expected from industry that they fully commit to a system that is still being invented when it should have been ready, as this jeopardizes any meaningful use of the transitional periods.
  • Notified bodies are in the middle: on the one hand they have to keep their business running and on the other hand reinventing themselves for Brexit and the MDR/IVDR application process take up a lot of their resources. I have heard that the audits for MDR/IVDR application are not a walk in the park at all and I think that especially for small notified bodies a large scope of designation will be very hard to pull off. While this is true for the bigger notified bodies that have an MDR/IVDR application in the water, the smaller notified bodies seem to have gone completely dark on what they are doing and what they are planning. The numbers of notified bodies applications for MDR/IVDR show that most of the notified bodies have not applied for MDR/IVDR designation. If you have a small notified body now with a full scope, better have a plan B and check if they have applied for MDR/IVDR, for what scope and if they expect to be able to support the scope you need. Don’t accept vague answers because they limit your options as manufacturer. It is unfortunate how only some notified bodies are trying to be transparent on where they are in the application process and what the consequences are for (AI)MDD recertification and MDR certificates. I appreciate that also for notified bodies there are a lot of uncertainties, but they can be clear on where they are in the process.

This shows that the highly decentralized EU system – which served the medical devices industry very well for a long time – now works against the objective of a quick and smooth transfer to the new system. Still, doing nothing is and remains your worst option – so, as the old Chinese proverb goes: are you going to curse the darkness or light a candle? If you light a candle, at least you might be able to shed light on some things and see them for what they are, which is always a good idea.

This is the time where everything you do as manufacturer is based on counting back from the Date of Application for your regulation (26 May 2020 or 2022), so you know how much time you still have to arrive where you need to be. Make no mistake, time is of the essence now. For example, if you are going for a renewal of your (AI)MDD certificate to extend past 2020, you should know when to hand in your application. That could be sooner than you think – according to a client communication of 2 July 2018 BSI requires it in the door by end Q1 2019 or they cannot guarantee that it will be processed timely. This means you may have to commit to an (AI)MDD certificate renewal before you are certain that your notified body is notified under the MDR. Have you got it clear what your notified body’s deadlines are and how this impacts what you are doing?

Also, if you have a UK notified body and a hard /no deal Brexit happens, do you know what this means for your CE certificates? The logical and legal consequence is that they will be invalid as of 30 March 2019 because the UK will be a ‘third country’ where no EU law applies as of that date (a transitional period only happens in case a deal is reached or if the EU is willing to unilaterally recognise certificates for (part of) their duration although the notified bodies that issued them have lost their notification) – do you have a backup plan for that?

Register for the seminar

If you’d like to join our seminar, please register here. As always, attendance is free and drinks afterwards in our newly expanded office space are on us!

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Bottlenecks, Brexit and stalling CAMD roll-out

Yoda IVDR

With the summer holidays about to happen and the halfway point of the three year transitional period for the MDR on the horizon, let’s take stock of where we are.

If you are a manufacturer and have just started thinking about this MDR or IVDR thing, you are in a bad place. Maybe you have a very limited number of devices that are subject to little change under the MDR or IVDR. In that case, count yourself lucky because you’re a happy minority. You may still have enough time to remedy your devices for MDR compliance in time.

I paint a general picture of where I think things are in my recent overview presentation at the Q1 conference in Washington DC half July:

Consider the EU version of this conference in Brussels 18-19 September and if you’re in the US, go to the Advamed MedTech Conference in Philadelphia 24-26 September to be informed by the EU panel. If you are a small or medium sized enterprise, definitely consider the RMD Symposium on 22-23 October, also in Brussels.

Manufacturers

Manufacturers can be found on a spectrum of urgency with MDR and IVDR implementation, ranging from catatonic denial / merry Titanic orchestra behavior to angry with the process to making this a historic opportunity to out-comply competitors. I see management just incapable of looking more than three months ahead and underestimating things monumentally, with Regulatory Cassandras leaving the company or pining away trying to complete an under-resourced MDR or IVDR project. And why would you resource it properly as company – it’s only core business, right?

I see also manufacturers starting to get in serious trouble occasionally when a notified body has their scope restricted or closes. They are suddenly faced with the need to find another notified body in a few months and find out that it’s not so easy to find a new notified body quickly these days. Most notified bodies that you would like to work with are stuffed to capacity and not taking new customers.

Those manufacturers also find out that if their technical documentation is not impeccable they usually has some additional things (mostly lacking clinical evidence) to sort out before the new notified body accepts the transfer, and that this may add up to a period of not being on the market. If you’re a listed company these are things your shareholders will probably like to know about and that you will need to disclose publicly.

Many manufacturers engage in homework practices similar to those of my twelve year old son: delay everything to the last moment and hope for a bailout if that turns out a bad plan. Is that a good strategy? That really depends who you ask. My son thinks so and normally there is a fair amount of cognitive bias in these discussions. People are not quick to admit that they might be better of leaving less to chance. As we will see below in relation to notified bodies, it’s a bad idea to push your remediation work and application for recertification for soft transition all the way back towards the date of application, because notified bodies have already started to indicate that they need the soft transition recertification applications in the door at least a year before the date of application. For the MDR, that is 8 months from now.

That period may already be too short if you need to do significant remediation work (e.g. do an additional clinical study to get your clinical evidence up to standards of the newest version of the clinical evaluation MEDDEV).

CAMD Roadmap roll-out seems to have stalled

When the CAMD roadmap came out in end 2017 I was very happy and full of hope: a plan! A roadmap! A plan! So far it turned out to be a dot on the horizon as the external production of items set out in the Roadmap seems to have been stalled. Behind the scenes I hear that the competent authorities are doing what they can, but that development of these documents is a consensual process and they can only do one thing at a time as their resources are limited. I tend to believe the latter part. One of the issues plaguing the EU medical devices regulatory system has been the systematic under-resourcing by member states and the Commission of oversight of this industry. Guidance promised in the Roadmap is not forthcoming and the Common Specifications and implementing acts required for the MDR and IVDR to function have not been adopted so far.

This under-resourcing is now proving to pose a bottleneck in itself for the development of all the CAMD items set out in the Roadmap, which risks timely implementation by companies. You would think that if you require industry to sink literally billions of Euros in MDR and IVDR remediation (some big companies come close to a billion all by themselves) to raise the regulatory bar that you would make sure that you have the regulatory infrastructure in place. By now I think the authorities’ party line that ’there is a lot you can do already’ has been used up as more and more companies are getting to the point that they have done what is there to do at this moment and are waiting for authorities now to hold up their part of the deal and provide not only for a theoretical legislative framework but a functional regulatory system.

The Commission published some very high level transition guidance for companies in the mean time, see here, here and here for MDR docs, here and here for IVDR docs. If the information in those documents is completely new to you, you know it’s time to up your game.

MedTech Europe has started to raise awareness for this because it’s obviously a bad idea for their members if there is a big bottleneck as a result of lack of sufficient notified body capacity and/or lack of a fully functional regulatory structure. MedTech Europe proposes three options to address the issues raised by the timeline for the application of the new Regulations:

a) A ‘stop the clock’ mechanism, that freezes the remaining transition time for both Regulations until full readiness of the system has been achieved;

b) An extension of the critical dates of 26 May 2020 and 26 May 2022, for all products;

c) An extension of the critical dates of 26 May 2020 and 26 May 2022, for legacy products only.

I myself am somewhat skeptical about these solutions at a European level (although I completely agree with the ideas behind them), as all of these require  changes to be made to the text of the MDR and the IVDR. That can only happen by means of re-opening the legislative procedure for the MDR and the IVDR. That is a procedure that is a) not fast and b) prone to everybody involved trying to change things they compromised on in the first place, which would delay things even more. This can only work if all the institutional actors in the legislative procedure are completely convinced about what needs to happen and completely agree on how this should work.

Notified bodies

With notified bodies some is good, some is bad and some stuff is downright ugly.

Generally speaking not only the manufacturers and authorities underestimated things, but so did the notified bodies. By 30 June  2018 the Commission had received 21 MDR application and 7 IVDR applications. This number may be distorted somewhat because it does not include applications (still) in the national validation phase. However, that phase is short, so the distortion cannot be that big. This is number kind of disappointing if you remember that applications could be made from 26 November 2017 and all Team NB members were very bullish about applying immediately for the whole MDR scope. We currently have 56 notified bodies notified under the MDD, and 21 MDR applications. We have 22 notified under the IVDD, and 7 IVDR applications – with the largest majority of IVDs needing an IVDR certificate under the IVDR.

Thus, it seems that a lot of notified bodies were way too optimistic to the point of almost being misleading. Also, applied for does not mean notified for. I hear about the numbers of non-conformities raised in the joint audits, which sometimes take the notified bodies considerabel time to remedy. However, sometimes also the members of the joint assessment team composed of the Commission and member states do not even agree amongst themselves on whether something is a non-conformity and if so, how it should be closed out. Obviously, this does not promote an expedient assessment and notification process.

Another complicating factor is that 30-40% of total EU notified body capacity is located in the UK, which has decided to recklessly become its own planet with supposed benefits by means of the Brexit. If there is no timely Brexit agreement between the UK and the EU to regulate the post March 2019 period well before end of March 2019 (because the EU and British institutions needs some time to validate any agreement reached), there will be a hard Brexit and this notified body capacity will be lost. A number of the 21 MDR and 7 IVDR applications are UK notified bodies, which means that a hard Brexit will eat into notified body capacity in a dramatic fashion with resulting in even bigger bottlenecks because this capacity cannot be replaced quickly.

Finally, there is the bottleneck compounding factor of all these new certifications for devices that did not need CE certification by a notified body before: reusable surgical instruments and software. Especially in the field of software as medical device the notified bodies have little experience because that is currently mostly self-declared, so almost no experts are available at notified bodies currently. In IVDs this is even worse because the large majority of IVDs is currently self-declared and the IVDR will turn this upside down (most IVDs cannot be self-declared anymore).

Manufacturers like to delay their remediation as much as possible, which means in practice a lot of relying on the soft transition period by planning to renew MDD, AIMDD or IVDD certificates one last time so they stretch beyond the date of application – if you’re lucky until 2024 if you can time your certificate renewal close to the date of application (26 May 2020 or 26 May 2022 respectively). The CEO will have moved on and everything will be clear by then right? Wrong, because what happens close to the date of application? Yep – everybody and their mother that is notified body notified for MDR or IVDR will be engaged in work regarding MDR or IVDR certification and will be frantically cranking out those certificates. This leaves no room for work that could have done before: the soft transition renewals. This is why BSI have recently started alerting their customers that any soft transition renewal applications must have been handed in by end Q1 2019, which is more than a year before the date of application for the MDR, and that customers cannot expect any recertification work to complete in the period of 9 to 6 months before the date of application. Other notified bodies have started to communicate November 2019 as a date to their customers.

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Too bad so sad if you planned everything to be handed in by beginning of May 2020 in the expectation of a quick rubberstamp renewal followed by a carefree maximum soft transition period. You may suddenly have to be ready a year earlier and only eight months from now. You are probably wishing now that you started this whole thing earlier. And remember: even renewal for the soft transition is no walk in the park if your technical documentation and QMS are not in excellent shape.

Naughty as business model

I am seeing some naughty commercial behavior on the part of the notified bodies as business model. Since they are often too busy at the moment, some make it into a business model to charge companies double fees to renew a certificate in time after they have moved the audit date back a couple of times themselves because they could not make the audit date for lack of capacity.

Or they don’t make the audit date before expiry of the certificate and then charge the company for an extra expensive entrance audit, sometimes with a period in which the company loses market access.

Not very nice, this kind of behavior. If, let’s say, the competent authorities for market access for medicines would act this way the world would be too small, but we are putting up with this from notified bodies while forgetting that they exercise delegated state authority (granting CE certificates that give right to market access). That should of course be exercised in accordance with all principles of good government.

So when you’re speaking with your notified body, count your fingers every time and don’t take maybe for an answer. It may be an expensive life lesson. Emergo’s Ronald Boumans wrote an interesting and very good white paper on this that I recommend reading. Notified bodies are not your enemy, but lets say that some are more customer friendly than others. I have spoken to several competent authorities about this and they say that this kind of thing should not happen – notified bodies are not allowed to make their problems yours and moreover charge you for solving them, and that they would like to hear about it when it happens.

Brexit

The Brexit process never ceases to baffle me. It’s an epic story of monumental political unpreparedness. It is everything Deadpool would call it, because he would use strikingly colorful metaphors. It’s the Monty Python 100 meters for people without sense of direction because up to this moment the UK still does not fully have its political ducks in a row as to what the UK actually wants from the Brexit – with the two years of transitional period almost effectively over. Even a reversal of the decision to leave is still on the table apparently, may be not even the worst option for the country.

The UK is now openly talking about having to stockpile food and medicines (which I assume will include medical devices too) in case of a hard Brexit. It does not have the resources to put in place all the mechanisms and people needed to fulfill all the formalities if it suddenly is not EU member state anymore as a result of a hard Brexit and will not have them by end of March 2019.

This, ladies and gentlemen, is what you get if you do not begin with the end in mind and allow politicians that have zero interest in a future beyond their own term in office to run away with the economic future of a whole country based shaky facts at best or outright lies and decades of underselling the economic and social benefits of the EU project. If you don’t agree with this statement, feel free to post a comment.

The Commission published a notice describing what a hard Brexit will entail for goods CE regulation but that’s of course not the only thing your company is concerned with. A Brexit will affect all your business in and with the UK in a truly fargoing manner.

The EU published a recent state of affairs and explanation of the further process. The UK published a White Paper that – in my view – is sitting on the fence of having your cake and eat it: moving out of the internal market for goods, while remaining part of its organization, its agencies and relying on free movement.

If you think the risk of a hard Brexit is remote, think again. The UK government says the chances of a hard Brexit are bigger than a controlled Brexit. Of course they’re blaming someone else for this, as typically happens in ill-considered divorces: it’s everyone’s fault but your own. You file for divorce and then blame the other for being inflexible in the following separation negotiations. Classic. So if you did not have a plan B for a hard Brexit, this is the moment that you start on one.

In the end the best the UK will be able to get out of the whole experiment is mutual recognition of good regulation without influence over its creation. So it will rubberstamp EU law (as it used to do as EU member), but will not have any influence over its creation anymore (while it used to have a lot of influence over its creation). If that’s not progress I don’t know what is. It’s the price you pay for not showing up to vote if there’s a referendum with a populist agenda I suppose. And who knows – it may be best choice ever even if all the facts currently on the table show that it won’t be.

Conclusion

A lot of moving parts in the MDR and IVDR implementation machine do not seem to be moving that well, hopefully for the moment only. Manufacturers are advised to not be passive with this going on: plan aggressively and not passively – your core business for the EU is at risk. If you are not informed, make sure that you are. There are many opportunities for the manufacturers that get it right and out-comply their competitors. But these will go to the expense of the manufacturers that get it wrong. From what I am currently seeing happen around me, these seem to be far too many.

IVDR and MDR implementation seminar

If you are in the neighbourhood of Amsterdam this Wednesday 18 April, consider dropping by for our IVDR and MDR implementation seminar because there are still some seats left.

IVDR is mentioned first here, because the seminar will focus on IVDs with our very special guest star Anja Wiersma who knows EU IVD regulations like few others. If you are an IVD company, this is your chance to increase your knowledge on operationalising the IVDR for your company substantially.

There will also be interesting stuff for both the MDR and IVDR minded regarding how to deal with (hazardous) substances under the MDR and IVDR, a notoriously tricky and difficult regulatory area for which we have secured the expertise of Jean-Marc Abbing, internationally recognized expert in precisely this field for medical devices.

Yours truly will update you on the progress of implementation, notified body designation, transition strategy, Brexit consequences and a focus on the Dutch implementing legislation for the MDR and IVDR.

As usual there will be drinks at our office afterwards and the seminar is free of course.

Register here!

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Batman MDR and IVDR update after the first MDCG / stakeholders meeting and an IVDR seminar

Batman and Robin MDR

You must be thinking that this blog is a bit quiet while a lot is happing – and that’s exactly the case. I’ve been very very busy being Batman (see picture on the left).

A lot of companies in devices still do not seem to get what the enormous change brought about by the MDR and IVDR will mean for them, and what they need to do to avoid suffering the consequences of ignoring the call of reality.

In the mean time the MDR and IVDR implementation roll-out rolls on and the transition period is ticking away – 26 May 2020 for MDR and 26 May for 2022 for IVDR. Yet, I still encounter management reviews that say “there is this MDR /IVDR, we have this person that is thinking about it, a plan will result, and we have until 2024 anyway, we will start doing something when we’re finished with MDSAP / ISO 13485:2016 / whatever”.

Are those dates in 2020 (MDR) and 2022 (IVDR) firmly between the ears of your whole organisation – including your management? Because it’s only core business, and a situation of perish or not. Sounds exaggerated? Well, its only about your company’s core business for the whole EU and other CE mark dependent markets. How could that be significant, right? Maybe consider bringing in Batman to set your management straight. You can be the good cop and Batman will be, well, Batman.

Just as a recap of things I have said often on this blog already, here is a presentation I did yesterday for an audience at the Dutch Standardisation Institute (NEN):

Show this to you management and tell them they are not Chuck Norris – only Chuck Norris can be a kamikaze more than once.

First MDCG – stakeholders meeting

In the mean time we’ve had the first stakeholders meeting with the freshly set up MDCG and stakeholders on 5 March. This meeting gave us a lot of interesting information about where things are and where they are going.

How will the MDCG work?

The MDR and IVDR attributes a lot of competence to the MDCG, which is composed of the delegates of the member states presided by the Commission. The MDCG will sit on top of a structure of groups much like the current MDEGs, which are currently transferred to the new structure.  The MDCG groups are currently going full pull in the roll-out of the CAMD roadmap. The CAMD has also produced helpful FAQs  for the MDR and the IVDR in the mean time – I recommend you check these out as they do actually answer questions . Also, stay tuned because I understand that the FAQs will be updated soon.

The MDCG structure is in the process of being set up and the existing structure of MDEG groups is being transferred to the new structure. Stakeholders will be invited to join all groups except those for market surveillance and joint audits in spring this year. A new cluster on new technologies and borderline issues is being set up.

Implementation of MDR and IVDR

Here is a non-exhaustive run down of implementation actions currently in the works:

  • The draft implementing act for reprocessing of single use devices will be made available for consultation soon. Highly relevant for any company that provides services of reprocessing;
  • A new draft implementing act on Annex XVI products (‘non-medical devices’) will be developed in the next months as the member states could not agree on the previous version;
  • Common Specifications for MDR will primarily be drafted by competent authorities (contrary to IVDs, where the stakeholders are in the lead);
  • Common Specifications under the MDR and IVDR will take ISO and IEC standards into account but will not copy-paste them and will be made available for consultation at the end of the drafting process; and
  • The CAMD implementation task force is working on more FAQs in addition to the first batch published earlier.The CAMD will set up a website where stakeholders can submit questions, which will be answered by a special inquiries group. This is expected to go live end of April.

Eudamed

Eudamed will be the database of databases for the EU medical devices and IVD system. The one database to rule and bind the other databases so to speak. You will not be able to place devices on the market in the EU without engaging with Eudamed, which is why this is an important project. The Eudamed roll-out is on schedule and looks to unfold along these lines:

  • May 2018 – The first functional testing starts – actors module is first (because best defined in MDR), devices module next shortly after
  • 25 May 2018 – MDCG accepts all functional specifications (as per article 34 (1) MDR)
  • Autumn 2018 – Eudamed WG comes with detailed functional specs for Eudamed so companies can develop interfaces
  • Q1 2019 – Further functional testing
  • May 2019 – Public Eudamed site goes online
  • September 2019 – Eudamed is ready for the formal audit (article 34 (2) MDR)
  • March 2020 – Eudamed goes live and notice in OJ (article 34 (1) MDR)

One of the big dependencies for Eudamed is the national process for assigning Single Registration Numbers (SRNs) to economic operators by the member states. You need an SRN for Eudamed to be able to recognize you. Assignment of SRNs are national processes that different member states must set up independent of each other, so companies must check in which member state they must request their SRN for which capacity of economic operator (manufacturer, authorised representative, etc.). For example, the Netherlands is now working on deciding how to do this and whether the government entity that manages the current class I devices and IVDs notification database should do this or not.

Joint assessments of notified bodies

The Commission and competent authorities informed that they feel they have made sufficient resources available for a timely joint assessment of all the notified bodies that handed in a timely application. However, they cannot guarantee anything regarding the time it will take notified bodies to correct the non-conformities found in the joint audits. So far they have experienced bottleneck issues not on their side but rather on the side of notified bodies, e.g. with meetings being scheduled late because lack of capacity on the part of notified bodies.

Notified bodies also seem (this is my observation) difficulties to maintain the personnel necessary for the scope that they applied for. In some cases just one person quitting pending the audit process can mean that the notified body is unable to qualify for the full scope that it applied for. This something you should closely monitor your notified body for. Does your device need a scope that is out of the ordinary (animal tissue, combination product, etc)? Then make sure that you monitor over time that your notified body applied for the required scope and keeps the people required for that scope.

Notified bodies have been told that they cannot consult, which means also not on what they expect the certification requirements to be under the MDR and IVDR, so no offering of MDR and IVDR pre-certification programs. This makes it more than extraordinarily important for companies to rely on excellent internal staff (if you have them, treat them well because they are worth their weight in gold) or excellent external advice (if you can find them, because consultants that still have capacity because they are just starting work on MDR and IVDR things are probably not the best).

The Commission planning is that the first notified bodies will be notified half 2019. Notification will take place on a first finished first notified basis.

In the mean time I have found that notified bodies are in disarray about what they can say and what they cannot say about their accreditation process (which is actually more than they often think or are willing to admit for competitive reasons), and for that reason sometimes put on a show of ‘all will be well’ or just completely clam up (and everything along that spectrum), or mislead by stating ‘intentions’ about scope and time of application and then not follow through. So be vigilant and take no bullshit from your notified body – in the end notified bodies are companies and they will always put their own interests before yours.

UDI

As you know, even though the MDR and IVDR contain quite a lot of detail on UDI, most detail is still to follow and an implementing act on UDI issuing entities is under development. Guidance on UDI is to be published this month.

Harmonisation

The Commission expects about 230 standards to be harmonised under the MDR, for each of which a mandate is needed, most of which are existing harmonised standards under the MDD and AIMDD. These mandates for the MDR and IVDR have not been given so far.

The Commission still has a love-hate relationship with international standards, because harmonisation remains a matter of doing gap assessments agains the MDR and IVDR essential safety and performance requirements. All ZA, ZB an ZC annexes to harmonised standards will need to be amended to the MDR and IVDR as part of this effort.  The Commission has indicated it will focus on processing the horizontal standards for the moment.

We will need to see how the Commission will act in common specifications (which under the MDR and IVDR can fulfill the role of standards) given the slow harmonisation process.

Corrigendum to MDR and IVDR

I understand that the European Commission is working on a corrigendum to the official texts that will be published in this year – there are little inconsistencies and small points here and there. This text will replace the current official texts that were published in the Official Journal on 5 May 2017. Expect no re-opening of the text – that would require another loop through the legislative process.

Work on vigilance

It was reported that the revision of the vigilance MEDDEV (2/12/1 rev 8) is ongoing. Templates for vigilance reporting into Eudamed will be finalized by October 2018 and then implemented into Eudamed. The Manufacturer Incident Report (MIR) form will be published in May 2018.

Clinical evaluation

The million Euro (or more even, depending on the product) is “when do you have sufficient clinical evidence?”. The good news is that the CAMD is are working on guidance on clinical evidence and equivalence, as announced in the Roadmap.

Interestingly, and contrary to rumors that I picked up before, MEDDEV 2.7/1 Rev 4 on clinical evaluation will not be amended anymore before the MDR date of application.

Breaking Brexit Batman!

Brexit batmanAnd then there is news on Brexit: a hard Brexit has been averted by the UK agreeing to a 21 month transitional period during which EU legislation will continue to apply in the UK with the UK having no influence over its creation (“leave Britain essentially a non-voting EU member until the end of 2020 to ease concerns for business“). In other words, the UK will be a kind of Switzerland from April 2019 to December 2020: bound by EU medical devices law with no formal influence over its creation. As a result, the dire situation painted by the Commission in its notice about the Brexit consequences in the context of CE marked goods is temporarily postponed. P-O-S-T-P-O-N-E-D, mind you, not averted. While the transitional period shows that the UK government has made remarkable steps in aligning with the realities of international trade policy, it is still not sure what the post-Brexit situation looks like. Actually, it’s not even certain at this moment what the situation will be regarding medical devices as there is no explicit confirmation at this point that the transitional period will mean business as usual for the medical devices system.

Also, member states governments are unable to positively confirm this at this moment, so this will need to be fleshed out more explicitly for the transition period. I’m saying this because the current draft Article 50 agreement (the agreement that is being negotiated for the UK’s withdrawal) is still firmly vague on whether the UK will have notified bodies that have any competence for the EU (like the Swiss currently have) – see article 42 of that draft agreement. Therefore, it is by no means a situation in which the devices world can now comfortably sit on its hands pending all of this.

More clarity to follow, hopefully. But don’t sell the fur before the bear has been shot, as we say in Holland, even after we exterminated our last local bear centuries ago.

National implementing legislation

Finally, companies should make sure that they are informed of the implementing legislation that the member states are working on currently. The MDR and IVDR leave lots of points for national discretion of implementation, and judging from for example the draft for the implementing act that the Netherlands is preparing I can say that member states like to go all out in their options because for them it’s a nice opportunity to recalibrate national policy.

An IVDR seminar specially for the IVD industry

I have noticed that there is a dearth of information for the IVD industry and that this may lead to many (especially smaller and non-EU IVD companies starting their implementation too late to be ready in time), so I decided to organise an IVDR specific event at my firm’s office in Amsterdam on 18 April, in the seminar format that you are used to from Axon Lawyers.

We will give specific attention to the CAMD Roadmap items for the IVDR:

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It looks like we may have an additional focus on the dangerous substances regulation for IVDs and medical devices in general, so if you’re interested in that, this is your chance.

We have secured the participation of Anja Wiersma of mi-CE (who knows EU IVD regulation like no-one else and is president of the RAPS Netherlands chapter) and a surprise industry speaker from the IVD industry.

So if you are in IVDs and have interests in the EU market you should attend – register here. It’s free and you can come with as many people as you like (just let us know how many). We’re not streaming or recording the seminar, because we believe that the best transmission of expertise takes place on a person to person basis. As usual we will seek permission of the other speakers to be able to publish all presentations on our website.

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An unsurprising case of software qualification with an interesting twist

logo-curiaThe unsurprising software qualification case that I wrote about earlier turns out to still have a little twist in the judgment that the European Court of Justice (CJEU) recently rendered in that case. The CJEU went into details that the Advocate General (AG) had not gone into so in the end the judgment turned out to be more interesting than expected.

Never a dull moment in medical devices regulation!

Unsurprising

As I blogged before when the AG opinion came out, it was completely unsurprising and expected that the the CJEU followed the AG and concluded that the software qualified as a medical device. The French government that was stubbornly defending its national rule requiring separate national certification of software that is used for support in prescription of medicinal products should have known better too, but it didn’t – as often happens with governments that should know better.

Still something interesting

The interesting thing happening in the CJEU’s judgment is the way the CJEU codifies crucial parts of the current MEDDEV 2.1/6 about software in case law. Why is this interesting? Three things:

Partial codification of the MEDDEV, which Member States may not depart from (anymore)

Because the CJEU borrows heavily from the MEDDEV and this way makes the MEDDEV law. All MEDDEVs state that the guidance is not authoritative and subject to interpretation of the directives by the CJEU. As a consequence, authorities can still do whatever they like and depart from the MEDDEV guidance even if this is totally clear (like the French State did in this case). However, they cannot do so anymore when the interpretation given in the MEDDEV is codified in case law because that constitutes a direct violation of EU constitutional law by the Member State.

In point 33 the CJEU renders the flowchart on p. 9 of the MEDDEV and its explanation in the MEDDEV case law:

“those guidelines indicate that software constitutes a medical device where it is specifically intended by the manufacturer to be used for one of the purposes set out in Article 1(2)(a) of Directive 93/42 and where it is intended to create or modify medical information, in particular by means of calculation, quantification or comparison of the recorded data against certain references, in order to provide information about a particular patient. Those guidelines further state that software that does not perform an action on data or performs an action limited to storage, archiving, lossless compression or, finally, simple search, that is to say, in the latter case, software that functions as a digital library and makes it possible to find information from metadata, without modifying or interpreting it, should not be considered a medical device”

It is now clear that the specific software, i.e. (point 34):

“software, of which at least one of the functions makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses, is, in respect of that function, a medical device, within the meaning of Article 1(2)(a) of Directive 93/42, even if such software does not act directly in or on the human body.”

This quote also shows that the CJEU does not accept the theory that “the software only provides information but the doctor makes the decisions” some companies tend to propose when they want to keep their software outside the scope of medical devices legislation.

It’s not completely new however that the CJEU refers to MEDDEVs when deciding on a question of qualification of a product as medical device. It did so before in the Brain Products case, point 24, but in almost no detail and on a rather insignificant point (“medical devices are intended to be used for a medical purpose” – duh).

Software qualification under MEDDEV 2.1/6 codified in case law and dependency with new software guidance

Secondly, we have the new MDR and IVDR that go into a lot more detail on software but not on the question as to when software is a medical device. Because the MEDDEV was written for the directive and therefore would not be valid for the MDR and IVDR (or at least would give authorities the opportunity to argue so) the fact that it is now case law is relevant. Since the MDR and the IVDR do not intend to change the definition of ‘medical device’ this interpretation of the CJEU must be carried over to the MDR and IVDR, while the Commission otherwise could have just repealed the MEDDEV and done something different.

This is extremely relevant for the discussions that are currently ongoing about a new piece of guidance about software under the MDR and IVDR as announced in the CAMD roadmap that I wrote about earlier (see point 2.2 of the roadmap). This judgment may influence the final text of the guidance and it may influence discussions in the IMDRF software working group because the EU cannot depart from this judgment, whereas it had a lot more freedom when there was no case law on software as a medical device.

Modules codified in case law

Thirdly, the CJEU addresses the modules chapter of the MEDDEV (a subject that the AG had not touched upon) and codifies that chapter basically, while there is no direct specific basis in the current directives or the new regulations. Sure, it follows from the logic of the system that modularization would be possible and that the manufacturer can decide which parts of a software suite deployed in medical setting have a medical intended purpose. But it was also beyond doubt that we were dealing with a medical device in this case and yet the French authorities fought this pretty evident conclusion all the way to the CJEU.

This helps under the MDR and IVDR in case of discussions with authorities or notified bodies about whether and how modularization is allowed. The most important point the CJEU makes is when it repeats from the MEDDEV in point 33:

“Those guidelines state that it is the responsibility of the manufacturer to identify the limits and interfaces of the different modules which, in the case of modules subject to Directive 93/42, must be clearly identified by the manufacturer and based on the use which will be made of the product.” (underlining added)

I underlined the specific words in this quote because I often find that authorities especially have difficulties accepting that certain choices with regulatory effects are the prerogative of the manufacturer solely, such as what are modules of a particular software suite, whether products sold together constitute a kit for specific IVD purposes or a system in the meaning of article 12 MDD or 22 MDR, etc. I find that in practice authorities have the tendency to substitute their intended use for that of the manufacturer in order to arrive at a different conclusion as regards qualification (medical device or not?) or classification (which risk class or which list for IVDs). But that is not how its works, and the CJEU confirms with this reasoning that it is the manufacturer’s choice only. As a result, the authorities can only make marginal appreciation of the choices that the manufacturer made by looking at whether the discretion that the manufacturer exercised is consistent with the intended use of the product as such.

So

What turned out to be an uninteresting case of a Member State being difficult for the heck of it turned out to have some interesting implications for the future after all. More legal certainty under the MDR and IVDR in the field of software as a medical device, what’s not to like?

 

Happy New Medical Devices Year!

19-009 Kerstkaart2017_DEFHappy New Year everybody – may your transition to the MDR and IVDR be unproblematic and timely.

May your management be convinced that making and selling medical devices is actually core business of the company and dedicate sufficient resources to your transition project.

Halfway point of MDR transition

2018 is the year in which we will see the halfway point of the MDR transitional period pass – if your company is not seriously working on transition, it risks serious disruptions in it EU business as of May 2020.

“But Erik, you start to sound like a broken record – we still have until 2024 under the soft transition.”

Well, yes: if you don’t mind that your device design is completely frozen after 2020 and you cannot change notified body or crucial supplier / subcontractors anymore. Only do this for non-essential devices or if you have no other options.

You will be captive to your crucial suppliers and notified body during that period. You won’t be able to significantly change the design of your device (e.g. when necessary as a CAPA). ‘Don’t postpone until tomorrow what you can do today’, my late grandmother would always say. She would tell you to be ready for the MDR sooner than later.

Are you with the notified body that you trust to have your back for certification of your devices under the MDR? Remember – no grandfathering – all devices on the EU market have to be recertified. Will the notified body be able to issue CE certificates under the MDR in time? It will be your problem if they are not and this may lead to significant business disruptions in the EU market. These are questions you should have answered last year already.

General Data Protection Regulation

2018 is the year in which the transition period of the GDPR ends (end of May) and all manufacturers must have implemented the new rules in the design of their devices, systems and software. This means among other things that risk management under the MDR and IVDR must be tied into cybersecurity measures under the GDPR. Medical devices IT design will have to cooperate with privacy compliance from the start of development of medical devices and related infrastructure. In a time of Meltdown and Spectre vulnerabilities going to the very core of your off the shelf components, how do you control your suppliers on these points? With cybersecurity more and more relevant, suppliers of off the shelf IT components may become crucial suppliers. You do not want to be the first medical devices company with a major data breach when the GDPR is applicable. And you should preferably not manage it like Uber did. The GDPR will really change a lot for medical devices companies.

Are you selling a medical devices company in 2018?

If you are selling a medical devices company in 2018 you should realize that the MDR and GDPR are your problem, even if you sell the company now.

The first thing that a buyer will look at in due diligence as gating items for EU compliance are a realistic MDR transition plan and readiness for the GDPR by May this year.

Prepare to have the sale price be discounted significantly or large parts of it deferred on the condition of MDR certification or GDPR readiness if your company has neither because in that case the regulatory risks are more than considerable.

It will be interesting

My prediction for 2018 is that we will start to see the first signs of companies realizing that they haven’t started in time and/or are not going to be ready in time, either because of their own planning or dependencies related e.g. to their notified body that will not be ready in time itself to process all the applications for conformity assessment under the MDR. It will be the year of early plan Bs and all the moving and shaking concerned with that.

The IVDR is still two years out, but IVD companies should be working on their (clinical) performance data like it’s 1999 because they risk running into the same issues, and they have the additional complexity that the notified body bottle neck will be even worse for the IVDR.

Also, 2018 will have the first big medical devices company data protection issue under the GDPR. Better make sure it’s not you.

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