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


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 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.


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.


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 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.


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.


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!


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.


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.

A wave of MDR and IVDR rollout coming our way

Schermafbeelding 2017-11-24 om 21.31.26With the clock for the countdown to the end of transitional periods for the MDR and IVDR ticking away, everyone is of course very interested what the competent authorities are doing regarding implementation of the MDR and IVDR, since a lot needs to happen to implement the MDR and IVDR. The Dutch competent authority gave some insight in planning earlier this year at a seminar organised by my firm.

The work to be done concerns three main areas:

  • delegated and implementing acts defined in the MDR and IVDR to make the system work (such as regarding the functioning of Eudamed and UDI);
  • EU level guidance on the many new concepts and procedures; and
  • National implementation in the fields where there is national discretion in implementation (e.g. in the field of whether and how to permit reprocessing).

The competent authorities have been busy in the background and have now produced a roadmap for implementation, defining priorities for seven technical areas and some horizontal / cross cutting issues.

Wait what? With 1/6th of the MDR transitional period already passed they are only starting to define priorities for implementation now? With not everything high priority or with even a fixed date attached? Yes, indeed and unfortunately – so better keep a close watch on the development and be ready to act quickly when the documents become available.

The document gives a good overview of responsible parties for each of the items in the lists, allowing you to see the new governance structure under the MDCG at work. 26 N November is also a memorable date (not only because it’s the date on which notified bodies can apply for MDR accreditation) because it’s the date as of which the MDCG is formally operational (see article 103 jo 123 (1) (b) MDR) and can start to get stuff formally organised for the big rollout program for the MDR and IVDR. Yay! We will then soon know more about its members and it will allow the newly set up MDCG to take a number of actions that are currently brewing in the background, which can be any of the things the MDCG is allowed to do, see articles 103 and 105 MDR / 99 IVDR.

The seven priority areas are:

  1. Clinical Evaluation & Clinical Investigation (MD); Performance Evaluation & Performance Studies (IVD)
  2. Scope & Classification
  3. Notified Bodies & Conformity Assessment
  4. Post-Market Surveillance & Vigilance for both MD and IVD
  5. Eudamed & UDI
  6. Market Surveillance
  7. IVD-specific Issues 

Let’s take a look each of these, and then discuss the horizontal priorities at the end.

Clinical Evaluation & Clinical Investigation (MD); Performance Evaluation & Performance Studies (IVD)

The MDR is about More Data Really (and the IVDR too) – that data being specifically clinical (MDR) and clinical performance (IVDR) data. It’s not surprising therefore that an important part of the roadmap is concerned with clinical and performance data and how to deal with it for the purpose of evaluation, conformity assessment and post-market follow-up.

This section of the document is part is the product of the Clinical Investigation and Evaluation Working Group. The plan is to develop templates for several clinical related deliverables prescribed in the MDR and IVDR, and its high priority:

  • Summary of Safety and Clinical Performance (MD)
  • Summary of Safety and Performance (IVD)
  • Clinical Evaluation Assessment Report (MD)
  • Performance evaluation plan and performance evaluation report (IVD)
  • Clinical Investigation application form (MD)
  • CI Assessment Report (MD)
  • Performance study Application Form (IVD)
  • Performance Study Report (IVD)
  • SAE/device deficiency reports and timelines (MD and IVD)
  • PMCF plan and PMCF report (MD)
  • PMPF plan and PMPF report (IVD)

I have understood that the recent 6 November meeting of the working group confirmed that MEDDEV 2.1/1 rev 4 really is guidance and not to be religiously applied written in stone rules (basically endorsing the view TUV SUD took earlier this year).

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The working group is working on a procedure for developing ‘device specific guidance’, which we should see as the precursor of new common specifications that can be issued under the MDR / IVDR. A draft of device specific guidance for drug eluting stents and bioresorbable stents is in the works. It’s not surprising that they started with stents, because some EU consensus on clinical evaluation of coronary stents already exists. Developing common specifications is also one of the actions under the roadmap’s clinical chapters.

Another item in the works is the development of template for the application dossiers and guidance incorporating medicinal products (MP) consultation, but this has low priority.

I hope this is the start of more harmonisation of clinical evaluation in the EU. We will see this come from the clinical evaluation consultation procedure (the procedure formerly known as scrutiny) and the development of common specifications, but any other harmonisation is welcome too, as it makes the CE marking process more predictable.

For more details, see the entire table in the roadmap document.

Scope & Classification

The items for scope and classification are as follows:

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An interesting point about the combination products and guidance is the issue that the no grandfathering principle raised for MDR certification of existing combination products. Does that mean that the full procedure (210 days) for medicine consultation has to be followed as referred to in Annex IX, 5.2 sub (d) for conformity assessment of devices incorporating a medicinal substance, or is this a ‘change’ that takes 60 days under Annex IX, 5.2 sub (f)? Nobody is sure yet for lack of an official position.

Another interesting one is that there seems to be a developing consensus that the combination products procedure under Annex IX, 5.2 also applies to rule 21 substance based devices.

Notified Bodies & Conformity Assessment

By now it becomes more and more clear that a lot of the initial assumptions about what notified bodies were going to apply when for what regulation and what scope are very fluid with the 26 November application opening date around the corner. Traditional notified bodies are applying later or not, or in a limited scope and new notified bodies enter the scene, with even some consultancies and companies applying for targeted scopes.

What is standard is that the notified bodies currently in the market are routinely vague to the point of being misleading to their (potential) clients about what they are actually going to do, and no notified body is very happy to tell you the exact scope for which they are applying. This makes is basically impossible to compare notified bodies, which is one of the big points in the legislative history of the MDR and IVDR with respect to the notified bodies: they do not actually compete because prices are not transparent, but now there is this too. So I decided to file a freedom of information request with the Commission after 26 November to ask the Commission to disclose information on this point so we can all benefit from some transparency. Keep a watch on this blog for the results.

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Not surprisingly many of the notified body related actions are high priority, like guidance to be issued on designation process for joint assessments under the new regulations. Yes, that would be nice – to have some guidance on this critical process. Better already too late than never right? The process of designation will be complex enough. Rather than create synergies the assessment under the MDR, the IVDR and the joint assessment for the current directives will happen each separately, putting an enormous strain on the limited competent authority resources.

An interesting one is the guidance on “What is a significant change?”. This will be crucial if you are going to rely on the ‘soft transition’ period, under which you can rely on a certificate under the old directives running past the date of application, provided that there is no ‘significant change’ to the device design or intended purpose. This is also an item below under the horizontal subjects. We know that there is some controversy between the member states on the exact interpretation of the concept of significant change, which may delay the formation of the guidance on this concept.

Guidance on procedure for notified bodies is also welcome, as it may provide much needed streamlining of conformity assessment for MDR and IVDR certificates towards the end of the transitional periods.

Post-Market Surveillance & Vigilance for both MD and IVD

In relation to post-market surveillance an important one is updated vigilance guidance (this will change compared to the current directives) and related terminology (you’ll need guidance indeed if you change so many well-established concepts – duh).

New template forms to replace the ones currently attached to MEDDEV 2.12-1 Rev 8 on vigilance will be developed too.

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Eudamed & UDI

In relation to Eudamed the million Euro question is of course if Eudamed will be ready in time and actually work. The focus in the roadmap is on interaction with Eudamed and UDI operational matters. Don’t forget though that even if Eudamed is not ready, the only obligation that the manufacturers will not have is actually inputting information in Eudamed. All the other obligations, like obtaining SRNs (you need one for application for conformity assessment for example, see article 31 (3) MDR) and also assigning UDI to devices, because that obligation is independent of registering the device in the database under its UDI.

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Market Surveillance

Nothing is urgent in market surveillance – what a relief. That doesn’t mean that not a lot is going to happen as the member states build up and tie together the whole EU enforcement backoffice. This is not a direct implementation issue for companies, but it is something to keep track of, for example to understand how the authorities will use clinical information as part of market surveillance, and how they will review clinical evaluation, performance evaluation and the post market data collection processes (last line under 6.5 below).

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IVD-specific Issues 

Most of the IVD specific issues also feature in the other streams above as you can see in the table. The only urgent priority are the reference laboratories – their designation and their function (see also below under 8.7 at the horizontal issues). Indeed – they are a gating issue for all class D IVDs for which there are no common specifications yet (IVD ‘scrutiny’ procedure) and there will need to be a common standard for assessing those, which there currently is not. The reference labs also play an important role under the IVDR to verify by by laboratory testing for conformity testing purposes the performance claimed by the manufacturer and the compliance of devices presenting the highest risk with the applicable CS (when available), or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent.

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It’s good to see an action item for a template for performance studies documentation and how to prepare and perform them. Given that most of the IVDs currently self-certified will need to go through notified body assessment based on significantly more and better presented data than currently likely available, this guidance will be very useful. Also the classification guidance will be useful because the IVD sector will need to learn to work with the new classification rules under the IVDR.

Notified body expertise and capacity for IVDs under the IVDR will be a very big item as I have observed before, so to me it comes at no surprise that this is an item for the CAMD roadmap too.

Over-arching & Cross-cutting Priorities

While sections 1 to 7 of the roadmap were sort of known already since April the section 8 on the over-arching and cross-cutting priorities is new. They are indeed priorities because everything in this section is high priority or even – exceptionally – has a date assigned to it (that’s Eudamed being ready).

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Interesting elements are the pre-date of application (DoA) and post-DoA questions, most of which have been raised on this blog already one way or another (I hope you’ve been paying attention). It will be good that there is guidance that companies can follow though in order to manage contingencies.

Contingency scenario development and planning is another interesting one, especially the supply problems that can take place in cases of low volume products. I would add to these the case of crucial healthcare software that is catapulted from class I to class III and does not manage to get certified in time and cannot benefit from the soft transition period. As things are in the software market single software suites can become a standard by themselves. If that software suddenly needs to be taken off the market as corrective measure (e.g. because of a critical patch that needs to be implement but cannot be because it changes the software installed base) or cannot be made available after the DoA this can have serious implications for health institutions.

How for do?

Please do not make the mistake to think that the fact that all of the above rollout and implementation roadmap is in development means that you can sit on your hands and wait until the documents have been released. You are smarter than an ostrich, right? A smart medical devices company is already doing what it can to be ready in time and sees all the guidance that will come out at some point as a welcome benchmarking exercise. If you start implementing by the time the guidance may be out (and we don’t know when that is), you will likely be too late to meaningfully act on it.

In way companies can see this roadmap as an overview of questions that they should be asking themselves in the frame of their transition program towards MDR and/or IVDR compliance. The specifics where guidance is developed are specifics that the company must pay extra attention to itself.

Companies that are underway with their transition process can take this in stride and supplement what they are doing already with the new guidance as and when it becomes available. Better pivot a little halfway than start too late to be in time, my late grandmother would say.


The new EU Medical Devices and IVD Regulations Workshop
In any event, if you’re based in the US, you could consider visiting the EU MDR and IVDR transition workshop that I’m giving at Advamed in Washington DC on 4 December to get the full picture and be prepared.

I will go into this stuff in a lot more detail in person too and you can ask any questions you have! Regardless of where you are in your transitioning process this workshop will be worth your while.

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