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.

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.

Workshop

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.

MDR and IVDR workshop at Advamed on 4 December

Schermafbeelding 2017-11-14 om 21.16.19At Advamed’s San Jose MedTech Conference this year it was quite a surprise for me to see how many US companies are still not doing what is necessary to become compliant with the MDR and the IVDR in time. In the EU MDR session at that conference about 5% of the audience raised their hand to the question what companies had a transition plan for these new regulations that they expected to finish in time before the end of the transition period.

This means that the rest of the companies represented do not expect to be ready in time, which is a problem since the MDR (and IVDR too) does not grandfather any products currently on the market. Companies just do not seem to understand this – every device currently on the market has to be CE marked again under the new rules. That’s a very big project, with very much at stake: essentially your European market as of June 2020 for medical devices and as of June 2022 for IVDs. We in the EU MDR session panel were stunned by this level of unpreparedness on the part of US medtech companies so I decided I wanted to do my best to remedy this.

How to make the transition and stay in the market?

I’m very proud and happy to announce that Advamed has decided to organize  an MDR and IVDR workshop at the Advamed offices in Washington DC on 4 December – quite soon already – which is called “The new EU Medical Devices and IVD Regulations: How to make the transition and stay in the EU market?”.

It’s a day-long workshop in which I will help your company make sense of the MDR and IVDR, define its transition goals and strategy, perform a gap assessment and come out compliant in time before the end of the transitional periods. It will be practical and there will be a lot of opportunity to ask questions. Also, I wil discuss how to develop your template documentation for a gap assessment and transition plan, provide starting material for that and discuss what moving parts to pay attention to as the EU is rolling out the MDR and IVDR.

Registration

Sounds good? You can register here. I promise you it won’t be boring – hope to see many of you then and there!

 

The notified body conundrum

ce_markIn my recent post about potential mass extinction in the EU IVD market as a result of the IVDR and the limited number of notified bodies that look to be applying for IVDR status (and the incredulous reactions that I received) I though it would be a good idea to update on notified bodies in general, and how they are doing with 26 November on the horizon.

You will have marked 26 November in your calendar, because this is the date that your notified body can apply for accreditation under the MDR and IVDR. It’s kind of essential that they do, because if they don’t, do it later or fail to make the cut you will find yourself in the proverbial chickenwire canoe in crocodile infested waters.

I have warned against notified bodies doing weird stuff in the advent of the MDR and IVDR, and now there is the Brexit too. I now see notified bodies now do exactly the kind of crazy stuff that predicted and then some. Customers are ignored or outright thrown under the bus while the notified body closes down, has its scope restricted allows certificates to lapse, is just unavailable to even explain decisions or schedule audits.

What do we see happen in the notified body market? I am not mentioning names on the record because I’m not looking forward to legal issues with any of them and I often don’t have multiple sources backing up the fact patterns. I am just describing what I see and what I’ve heard myself and what others have told me.

Abandoning codes

The EU is consulting about the new notified body NBOG codes. Notified bodies apply for a designation under these codes, which together define the scope of the notified body. Your notified body is also already designated on the basis of the current NBOG codes, which describe its current scope. Two things are happening right now:

  1. notified bodies are ditching current codes because they can no longer support them. I’ve seen at least one notified body has sent its customers a letter that it no longer will support a specific code and terminating the mandate unilaterally for the certificates in that scope on a few months notice.
  2. informing manufacturers that they will apply for a more limited scope under the MDR or IVDR than currently, which may mean that the notified body cannot support the client under the new regulations. Some notified bodies that currently do IVDs will not for example apply under the IVDR, or not immediately, and the same likely to happen under the MDR.

These things are happening for a number of possible reasons. The notified bodies are strapped for resources required under the MDR and IVDR and a lot of people are on the move. This may even result in notified bodies having to restrict their scope as a result of crucial staff leaves – most notified bodies are this thinly staffed for some of the more exotic areas.

Scenario 1 is not nice because you have to find a new notified body rapido for your continued compliance under the MDD. The limitation in scope may have all kinds of causes, but it does mean that if you don’t have a new notified body by the time that the notified body mandate terminates you are officially orphaned – which is a problem because there is no EU law or national provision that can help you.

Fortunately it appears as though the heads of agencies for medical devices have agreed to a procedure that allows you to enter the orphanage of temporary competent authority supervision to allow you to continue to place product on the market for up to 12 months while you find a new notified body. The first two agencies to apply this were the French and the Swiss. Not every competent authority for medical devices is equally clear about it but the Dutch one has published the procedure that was apparently agreed on its website in great detail (in Dutch unfortunately). This procedure seems to replace / amended the NBOG procedure for ‘enforced change’ of notified body that applied since 2006.

You will need to apply to the competent authority of the EU member state in which you are established as manufacturer or (if the manufacturer is not established in the EU) in which the authorised representative is established. You will have to prove to the authorities among other things that:

  • you will maintain the QMS until recertification by another notified body; and
  • that you are actively seeking the services of another notified body, including a summary of the status and the prospects of finding one that will re-certify the devices concerned and when.

You will also need to provide:

  • details of your PMS system, recent PMS reports and management review relating to PMS and vigilance; and
  • an overview of incidents everywhere in the world over the last 36 months (per country and number of products sold); and
  • an overview of open, started and finished CAPAs caused by incidents over the last 36 months (including cause, root cause analysis, conclusions and solutions).

Essentially you have to satisfy the competent authority that the safety of the medical devices concerned has been safeguarded pending the transition to another notified body. If you cannot convince them, you are an orphan without orphanage and will not be able to place the devices concerned on the market once the outgoing notified body mandate terminates.

Of course, during the transition under the supervision of the competent authority you cannot make any changes to the devices that would require notified body scrutiny or market a new device that was not covered by the certificate(s) at the outgoing notified body.

This is of course a really raw deal, especially since notified bodies have become very hesitant to accept ‘like for like’ or ‘transfer in good stead’ transfers in even the most amicable of scenarios, as they cannot be sure that the underlying file can be easily certified and in practice often don’t have the resources to do a new entry certification. Also, the NBOG guidance on enforced changes states specifically in cases of ‘foreseeable breakdown’ of a notified body that “[i]n this case a new certificate should not be issued solely on the basis of the previous NB’s documentation but a separate review of the manufacturer’s documentation and/or a site visit by the new NB may be necessary.” Also the new procedure published by the Dutch authorities seems to assume a full new entrance audit by the new notified body. This means that any notified body that is willing to accept you also needs to have the time available to do this, and in the short term.

Informing that the notified body will (probably) not apply under MDR / IVDR

Some notified bodies inform their clients that they (probably) will not apply for accreditation under the MDR and/or IVDR. That is a problem because this is not a notified body breakdown scenario of an ‘enforced change’ legally speaking because there is no ‘withdrawal of designation by the Designating Authority (partly or completely) or voluntarily abandons its designation (partly or completely)’ or liquidation of the notified body that causes the client to be orphaned.

The effect is however exactly the same as that in an orphaning scenario, except that you cannot ask for temporary under the umbrella of the competent authority temporarily.

This affects a large number of notified bodies. As discussed in an article in MedTech Insight on 18 September, notified body association Team NB expects that “at most 16-18 of its members will be ready to submit by late November. And given the potential for non-conformities to be identified in some of the applications, the association would be pleased to see 10 of its members get designated against the MDR/IVDR in the first wave.” I’m not sure if these numbers have changed since September.

This means that the association that previously said that all its members will apply at the same time so as to be designated all together at the same time has back-pedaled considerably on its members’ chances of making the MDR / IVDR cut. Five to seven members may not apply on 26 November, with the number of those that will not apply at all being unknown. I know of at least one that is already telling its clients it will not apply at all.

This is of course even more problematic in relation to IVDs because of the low number of notified bodies allegedly applying for accreditation under the IVDR (only five). Given the quantum leap of self-certified IVDs currently on he market that will need notified body certification under the IVDR (80-90% of the total IVDs will need notified body certification), it is already doubtful if the combined capacity of those notified bodies will suffice. The bottleneck that will occur under the MDR towards the end of the transitional period will likely be much worse IVDs.

[UPDATE: Team NB just published an overview of the intentions of each of its members regarding to application for MDR and/or IVDR accreditation, which now shows that all members intend to apply for MDR accreditation and 11 members for IVDR accreditation. As is clear from information on Team NB’s website this does not mean that all members will submit immediately. Some intend to submit in December and some intend to submit whenever.

Also, the intention of application as such does not say anything about the codes for which the notified bodies wil apply. It would have been helpful if we would have known if they intend to apply for the same scope or not. I’m very curious how these intentions relate to the earlier statement of Team NB itself and of course how they will translate to actual applications.

Finally, given the statements of some of the notified bodies themselves discussed in this article, I’m inclined to say: “seeing is believing” and would encourage all readers to check with their notified body (since all Team NB members intend to apply for the MDR at least) why they were making contrary or unclear statements before, whether they will really apply on 26 November, later or whenever and for what scope they will apply. Oh, and of course how they see their chances of actually getting accredited and when. Please share your findings in the comments to this blog post so the other readers can benefit too!]

Allowing certificates to lapse

Another particularly nasty scenario that I have observed happen to at least one client is just not respond to requests to please schedule the recertification audit and just letting the certificate lapse. This can happen either because the notified body has no personnel to actually do the audit or because it applies a proces of Verelendung (immiseration) on its clients to drive them away in the most negligent of ways.

Not applying at first opportunity

There are also notified bodies that will not apply for MDR and/or IVDR accreditation at the first opportunity on 26 November, but who will take their time to get ready. As is clear from the Team NB statement mentioned above, five to seven of its 23 members will not be ready to apply on 26 November or may not apply at all.

This may mean that they may suffer delays in being accredited (e.g. because they will not be in the first wave of joint audits) leaving less time to process manufacturers’ requests for  MDR / IVDR certification before the end of the transition period. Guess whose problem that will be when the notified body does not manage to get you certified in time.

Move to another jurisdiction

General unavailability may be influenced by a notified body having to literally reinvent itself because it is moving to another jurisdiction. The candidates for this are the UK notified bodies (because of the Brexit) and possibly the Swiss notified body (hedging with respect to renegotiation of the new Mutual Recognition Agreement between the EU and Switzerland). Having to move jurisdiction will mean a new notified body under new jurisdiction, and not keeping the old number. If your notified body moves before it is MDR / IVDR accredited you may need to change your labels twice. This is a realistic scenario for the UK notified bodies, because the Brexit transition period ends March 2019. At least one of them will go to the Netherlands (BSI) and I’ve heard rumors about Belgium, Ireland and Germany for others.

A move to another jurisdiction may also coincide with a limitation of the notified body’s original codes, because the new jurisdiction may not support the same scope. Also, a scope reduction may be necessary because the notified body looses crucially competent staff in the move to the other jurisdiction.

Turkey

If you have a Turkish notified body there is yet another issue: Turkey is allowed to have notified bodies for the three medical devices directives because these three directives appear on an annex to a 2006 decision of the EU-Turkey Association Council, which lists the EU instruments for which Turkey will fully harmonise its laws with the EU directives.

Guess what: the MDR and IVDR are not on that annex (meaning that for the moment Turkey is officially not implementing the MDR / IVDR) and we don’t know if or when they ever will be on that annex.

Given the current tensions between the EU and Turkey, it may be that Turkey doesn’t even want to have notified bodies and/or the EU does not want Turkey to still have notified bodies for medical devices for the MDR and IVDR.

Bottom line: if you are relying on a Turkish notified body for an MDR or IVDR certificate, this may not be your best option.

General unavailability

I hear from many clients and others in the market that their notified body is struggling to respond to questions and simple requests, like ‘please explain why you took this decision’, ‘what does this mean’ and ‘what do you want’. This may be caused by a variety of reasons having to do with notified body operations, and it is very annoying because it costs time and creates insecurity for  the manufacturer waiting  to get clarity on sometimes even simple things. Time is especially scarce these days, with the transitional periods for the MDR and IVDR running.

So now what?

What if your notified body orphans you, immiserates you, just doesn’t apply for MDR / IVDR accrediting or does not certify you into the MDR / IVDR in time?

Will you sue them? It happens often that companies that do not get what they want ask me if they should sue the notified body. It’s a good way to help me buy a new Porsche – I’ve had my eyes on the new Panamera for some time. However, it’s a bad way to get where you want to be. Even if you manage to prove that the notified body acted grossly negligently in the way it handled your certification process (already not very likely that you manage), the chance that you will get the court to rule that the certificate should have been granted on the basis of the dossier supplied is virtually nil. The court will – in that case – hand the case back to the notified body for another look. In the mean time you will have wasted at least a year without a certificate that allows you to place devices on the market while I have my Panamera and your competitors have your market share.  The reason that I don’t have my Panamera yet now however is that I don’t advise companies to embark on legal procedures that do not serve the company’s goals. Diplomacy and having really good documentation and clinical data supporting the device(s) concerned is more likely to get you results and certificates. Better spend your money on excellent and convincing clinical data and technical documentation than on subsidizing my Porsche. Really.

The best you can do is to find a new notified body quickly and be pro-active about it. If you initiate a transfer that is voluntary the new notified body may accept the existing file without doing a full entrance audit. The better your files and data, the higher the chances that you succeed in the short term. If you need to change notified body or are thinking about it because your notified body seems to be on a road to nowhere lately, change sooner rather than later. Later in the transitional periods the notified bodies that do make the cut will be completely swamped by existing clients to have their existing devices certified into the MDR and IVDR. They will not be looking for new clients. The other notified bodies will have more time, but no MDR or IVDR certificates to grant.  The only thing they can do is to renew the existing certificate once for a limited period of time (and with the disadvantages of the so-called soft transition – no design changes, no certificate changes, no supplier changes, but full MDR / IVDR compliance required otherwise).

Once you are safely transferred to another notified body you might still try to sue your former notified body for damages though, but at least you can take your time for it. And we know from the EU Court in the mean time that notified bodies may be liable for negligent oversight. Betting on getting a court to replace the notified body decision with its own judgement is however unlikely to happen (provided that the court is even allowed to do so under local procedural law).

Interesting times, in which you should definitely not sit on your hands complaining that it’s all too complicated to know what to do. Better leave that to your competitors.

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