Brexit is a fact – now deal with it

so-long-farewell-and-auf-wiedersehen-goodbyeFollowing the European Parliament’s vote, the Council has now also agreed to the Brexit with its decision on the conclusion of the withdrawal agreement on behalf of the EU. The EU Parliamentarians sang off the UK members and celebrated that they never have to speak to Nigel Farage again. UK EU civil servants are clearing out their desks at the EU institutions.

This means that the UK will now, after a long and winding process, finally leave the EU by 31 January – which is tomorrow.

But will it really? In fact, the UK will become a third country in which EU law applies for possibly years to come, but that sounds a lot less glamorous of course.

I am getting questions from all directions again so let me reiterate for you how this thing works, on top of my earlier blogs on the subject or mentioning the subject. I will also put in some political analysis.

To understand the Brexit you have to realise that it’s a multistage thing:

Stage one: UK = 3rd country with EU law per 31 January

The withdrawal agreement will enter into force upon the UK’s exit from the EU, on 31 January 2020 at midnight CET. From that time on, the UK will no longer be an EU member state and will be considered a “third country”. But that does not mean they are “out” yet. Or in terms of the MDR: that they have ceased to form part of the Union for the purposes of the MDR and existing directives. This is not the case yet because EU law continues to apply.

By 31 January midnight the Brits can say that they escaped the tyranny of the EU because they are independent again and the British tabloids will run patriotic hyperboles about the UK having regained control over its own destiny again. Except the UK is not independent yet, likely not for years to come.

Stage two: transitional period from 1 February to 31 December

From 1 February to 31 December 2020 there will be a transitional period, to provide more time for citizens and businesses to adapt.

During the transition period, the UK will continue to apply Union law but it will no longer be represented in the EU institutions. In other words, nothing changes except that the UK continues to apply EU law and has even less to say about creating and interpretation of EU law than Liechtenstein or Iceland. Many companies will sit on their hands as usual and not prepare for the Brexit at the end of the year.

In the mean time, the EU and the UK will try to put their ‘future relationship’ in international agreements and law, along the lines of the political declaration of October 2019. The negotiations on the future partnership between the EU and the UK will start once the UK has left the EU.  These negotiations concern many difficult subjects, like fishing rights and free movement of persons, that may well not be resolved before the end of the year, most likely leading to stage two and a half (see below).

Anticipating phase 3 (see below) the UK will want to conclude all the fabulous trade deals with other third countries that it has promised its population. However, in practice it will find itself bullied by the US and the Chinese now that the UK is much smaller than it was as EU member while trying to stay connected to the EU market at the same time.

Being fiercely independent while securing maximum access to the EU internal market will be a complex game of chess on multiple boards that so far has not gone well for for example the Swiss, who are now ground up between their voters and the EU because these two cannot seem to align and find themselves in the by now completely realistic Swixit scenario in which Switzerland will (temporarily . They have been negotiating for six years almost about what the UK would try to do before the end of the year. Given the record of the UK internal chaos when even coming to a Brexit this will never happen in time. Also, these new deals cannot enter into force during the transitional period.

The transition period can be extended once for a period of up to one or two years, if both sides agree to this before 1 July 2020. This is the likely scenario, because the UK is way not ready to leave without a lot of open ends by end of the year and the EU has shown to be sensitive to a chaotic exit, so the scenario I expect this to happen unless the EU is done with the UK at some point and refuses to extend.

Stage Two and a half: extended transitional period

The most likely option therefore is extension of the transitional period. The UK will continue to apply EU law. It will be worse off than Norway, Iceland or Liechtenstein because just applies EU law without even sitting at the table without having nothing to say.

This will be a two year extension. Companies that were sitting on their hands will start to believe that it will never happen and sit on their hands even more.

After the two years, the UK will truly be out because EU law will no longer apply and the MDR/IVDR will not apply for the UK any more.

Maybe there will be a transitional regime at the end of the extended transitional period, but nothing’s certain. The UK may have implemented the MDR and the IVDR but the EU may not recognize UK MDR and IVDR absent a mutual recognition arrangement, of which we do not know what it will look like.

EU law may continue to apply because of an extension of the extension, as described in the following scenario two and three quarters. If that scenario does not happen, go to stage three.

Stage two and three quarters, four fifths, nine tenths etc

Theoretically, there is nothing to prevent the UK from not getting its act together in the additional two years. In fact, this is likely to happen given the track record of UK negotiating with the EU without internal mandate or a mandate that turns out not to be a mandate.

It may therefore be that the transitional period is extended, possibly repeatedly, as the UK and the EU prolong the transitional period to avoid a chaotic no-deal Brexit that nobody wants. However, EU law will still apply during this period.

Then, at some point, the UK and the EU will decide that enough is enough and that the exit is deemed manageable. The UK leaves and EU law ceases to apply in the UK. Companies that are still not prepared by then will suffer the consequences.

Stage three: the UK finds out its place in the world and who’s next?

This is the UK endgame that the whole thing was about in the first place, in which statues of famous Brexiteers show up on squares in the UK and Britain is made great again. The UK is alone in the world and will likely quickly find out that the smaller you are, the more likely it is that you are pushed around by richer and/or more powerful countries that are only your friend when it serves their own purposes.

The Chinese and oil money from the Middle East will buy most of the UK, while the Americans will bully the UK into great deals that are far less advantageous for the UK than thought originally. The UK will find out that China is a lot bigger than they thought.

The Chinese and US will increase their efforts to prying the next member state(s) loose from the EU, because the best EU for the rest of the world is a weakened non-unified EU. This process is already well underway but will be played out more in the open. The EU, for its part, will do its best to keep the remaining member states in a row and counteract external and internal forces of division that would weaken the EU. Being a citizen of one of the founding member states and having an international outlook, I of course hope that they prevail.

In stage three anything can happen, for example:

  • The UK is Union and applies the MDR and IVDR, UK manufactured or imported devices may circulate freely in the EU market; or
  • The UK is fully third country, and uses its own certification scheme. The UK and EU may mutually recognize certifications; or
  • The UK and the EU don’t get along very well, and there is no mutual recognition. UK manufacturers and importers will need to obtain additional CE marking for the Union market.

Scenario anyone?

As you can see, it’s not a binary process of leaving but rather a gradual one and as I have been saying you should prepare for this by having plans for various scenarios – including the ones I came up with in this blog and possibly others. Everything I have written on this blog in relation to Brexit (also here and here) is still relevant, unfortunately we just don’t know when. Read up on old and new guidance. Questions? Confused? Angry rants? Let me know.

 

 

 

Welcome to 2020 – year of the proof of the MDR pudding

Tom Hanks golden globes MDR.jpgWelcome to 2020 – happy new year everyone. I don’t care if your conventions do not allow me to wish you best wishes after a certain date anymore. I wish you a happy 2020 because I genuinely hope you will have it. If you are a reader of this blog and you have a happy 2020, it will mean that a lot more went right in the MDR roll-out than I would expect based on the outlook at this moment.

Over the Christmas holidays I wrote my contribution to the Dutch Health Law Association’s 2020 periodical book discussing developments in healthcare regulation  (in case you read Dutch: Preadvies van de Vereniging Gezondheidsrecht), which is about medical devices law this year. It will be published spring 2020 and my conclusion is not different from my not so happy Christmas carol post just during the Christmas holidays 2019 (which I wrote as I was writing the contribution to the book).

The reality of things

HandThe reality of things is that things are heading to an urgent critical mass (or mess, pun intended), because there is less and less time to make a meaningful difference.

We have about five months to go to the date of application of the MDR. Five is not much. It’s the amount of fingers on your hand – I’ll borrow you mine to make the point. See: only five fingers. Not that many. A fast typical conformity assessment under normal circumstances takes at least six months. Six is more than five. This means that even theoretically no additional notified body added in Q1 2020 will make a a difference before May 2020.

When I wrote the Not so happy Christmas carol post last December some people thought I was being overly negative and I even started believing that myself at some point.

But then I resumed work after the holidays and the reality of the devices world washed over me again with clients asking my advice in an avalanche of problems and with signals that I see in the market:

  • clients facing massive delays in any interaction with notified bodies;
  • clients approaching notified bodies for the first time are not able to find any notified body that will onboard them;
  • clients facing notified bodies ‘offering solutions’ that will costs them double or more just for the notified body to renew a certificate in time for it not to expire;
  • notified bodies ‘notifiedbodysplaining’ how their capacity is tied up to the extent that they are unable to make any predictions about certification decisions, not for (AI)MDD recertification and not at all about MDR certification;
  • health institutions being mostly oblivious about what the MDR and the IVDR will mean for them (or in vicious state of denial about the in-house production regime);
  • class I manufacturers mostly having absolutely no idea what the MDR will mean for them and not understand at all that there is a large gap to cross;
  • independent distributors far and wide not wanting to touch the MDR with a 10 meter pole (yes, that’s more than 10 feet as the expression is originally phrased) and distributors calling themselves ‘wholesalers’ flat out denying that they are in scope of the MDR and IVDR, even though they evidently are;

And the list goes on. My pessimism is back.

The system is not antifragile and has an agency problem

Schermafbeelding 2020-01-10 om 09.18.41.pngWe ended 2019 with the new Commissioner for Health jedi mindwaving the member states about the status of Eudamed and notified bodies and what that means for availability of medical devices on the EU market. Nobody seemed willing to admit publicly that the EU regulatory system for medical devices has not been designed to deal with the enormous spike in notified body and authority capacity needed for the transition to the MDR and to the IVDR. The system can just about operate at nominal capacity in its fragile equilibrium of structural under-resourcing, but the MDR and IVDR did nothing to make the system antifragile (i.e. capable of becoming sufficiently robust under stress) enough to deal with the efforts required for the enormous bulge in the pipeline resulting from the fact that all notified bodies needed a new accreditation and all certificates need to be re-issued under new criteria. In essence the MDR and IVDR have been set up as a massive agency problem waiting to happen, and that’s exactly how it unfolded, or in the words of Nassim Nicholas Taleb describing the agency problem:

“Situation in which the manager of a business is not the true owner, so he follows a strategy that cosmetically seems to be sound, but in a hidden way benefits him and makes him antifragile at the expense (fragility) of the true owners or society. When he is right, he collects large benefits; when he is wrong, others pay the price. Typically this problem leads to fragility, as it is easy to hide risks. It also affects politicians and academics. A major source of fragility.”

It also affects politicians – and indeed it does for the MDR and IVDR.

The lack of capacity is being felt keenly an acutely by stakeholders, and is mostly managed badly for a lack of options and resources. I have come up with a thought experiment that I would encourage everybody (and especially authorities) to apply to any situation MDR or IVDR related to expose the agency problem. Ask yourself in every situation: “Would we be OK with medicines agencies operating this way?”. Think about it. In many situations ‘the world would be too small’ (paraphrased Dutch expression) because it would be inconceivable in relation to medicines that the system or the government agency responsible operates this way. Notified bodies, however, are almost never government agencies, but they do exercise government authority.  Some examples I have come across, for your consideration:

  • After accepting your application the registration authority says it will double registration fees and otherwise not finish your application process in time for your existing authorization to expire.
  • The registration authority says it is not going to finish your application in the time frame promised, because it can actually not promise anything because it’s so busy and literally tells you that if you don’t like it, you are welcome to go to another agency.

Would we like the EMA or the national medicines agencies to operate this way? Hands up if we do, and please send in a comment if you think this is a good idea so we can propose amendments to basic principles of good administrative practice.

The bottlenecks summed up (again)

Schermafbeelding 2020-01-10 om 12.03.34The reality of things is that even if the Commission is emphasizing the small successes (yay, another notified body accredited or look here, another guidance document published) and the Member States are doing their absolute utmost to trust the Commission when it is totally Jedi mind waving them, they’re not fooling anyone else.

MedTech Europe published a very clear and accurate paper that sums up all the bottlenecks, and shows that each of the possible ways to have devices on the market post May 2020 (an MDR certificate, a renewed (AI)MDD certificate or a national/Union-wide exemption) is affected one way or the other by the critical lack of capacity. They also point to potential solutions for each bottleneck, which I am not repeating here – please read the paper, it’s important. Spoiler alert: most of the solutions are to deliver as soon as possible on what should have been delivered years ago. This is also not new, but more urgent than ever.

I will summarise the bottlenecks (again) and invite you to read the MedTech Europe paper for the solutions.

MDR certificates

There are insufficient MDR notified bodies accredited to make the difference, essential guidance is lacking and the system is not ready in many respects and for certain devices. It takes notified bodies considerable time to get up to full accreditation speed after they have been accredited and even under the best of circumstances it takes at least half a year to process a conformity assessment application. The fact that a notified body has been accredited does not mean that it will be able to make the difference before 26 May 2020. The notified bodies accredited in Q1 2020 (including the remaining eight promised for 2019) will likely not issue a single certificate before the date of application of the MDR.

Renewed (AI)MDD certificates

There is not even enough capacity to renew all the existing certificates for the 2020-2024 grace period, and there is complete unclarity about what the duties of notified bodies overseeing these certificates past May 2020 are. As things stand, they can give any manufacturer three months notice, leaving the manufacturer in a situation where it will never ever be able to have an MDR certificate at another notified body (too busy, and takes (much) more than three months) and it is uncertain whether the orphaning procedure in article 46 MDR applies only to MDR certificates or also to (AI)MDD certificates valid past May 2020 based on article 120 (3) MDR. And there is still the uncertainty around the interpretation of the concept of significant change, which can invalidate certificates just like that. The fact that the guidance promised by the CAMD in December 2017 is still not here is quite frankly astounding.

Also, there is (still) no solution for notified bodies not renewing a certificate in time, or refuse to accept the renewal application.

National and EU exemptions

As under the old directives the primate of exemptions to CE marking remains with the Member States under the MDR. There is a possibility for extending a national exemption to the whole Union territory pursuant to article 59 (3) MDR – which means that there must first be a national exemption that applies to one Member State. Each member state may use their own criteria for that, which often involve that the exemption is the exception, i.e. not intended as a general alternative market access mechanism for everyone that could benefit from it. You will also often need to show that you are on board with a notified body already, which is kind of problematic because most are not accepting new customers at the moment.

Subsequent extension of the exemption to the whole Union (so the manufacturer does not have to make an application in each Member State) based on article 59 MDR is limited to ‘exceptional cases relating to public health or patient safety or health’, so not intended as a general exemption for everyone in trouble it would seem. And each exemption needs its own implementing act under the MDR to be adopted under the examination procedure, which looks like this:

adoption implementing act examination procedure.jpg

As you can see, not complicated and slow at all – not. Quickly change the MDR for a more streamlined and quicker process perhaps? Not enough time to do this before May 2020.

Furthermore, it is not clear whether it is allowed for devices exempted this way to affix (or keep affixed) CE marking. If this is not allowed, this will  severely impact exports to third countries that allow devices on their markets based on CE marking.

You finally really seem to be doing it

Planet of the apes MDROne of the most powerful images that I can come up to underline the sense of urgency of this all is the final scene of the first Planet of the Apes movie.

Charles Heston’s character realizes at the end of the movie that the barren and primitive place in which he found himself the whole movie was in fact the post-apocalyptic earth. Would we like a health system just as barren as that of the planet of the apes? Maybe watch the movie for yourself to get an impression but (spoiler alert): the planet of the apes is missing a lot of nice to have and innovative medical technology that used to be available because it is kind of primitive. Of course this is a dramatic example, but I am running out of ways to express the urgency of the problem.

MedTech Europe politely captions its paper with “A Call to Action” because they have to be polite. I have less constraints and will be less polity because I am a (potential) patient myself, I have family members that depend on medical technology for their life, and others for their quality of life. And I am truly upset and disappointed about what we have to show for the MDR implementation at this moment (and don’t even get me started about the IVDR). I would like the best regulatory system so everyone can have access to the best and most innovative medical technology, not to the bare necessities only because we could not be bothered to make the regulatory system work.

Of course in the end the politicians will say it is nobody’s fault (agency problem anyone?), except that this would be wrong. The writing of things coming to this critical mass has been on the wall for a very long time, just read back this blog three years.

Let’s realize that we are all (potential) patients and want the best for our loved ones, ourselves and why not society at large, and make this thing work by adding clearly needed antifragility now that there still is some time. All the solutions are there, we know them, MedTech Europe helpfully repeated them. And the rest is politics.

A not so happy MDR and IVDR Christmas Carol

MTE MDR 123.3d workshop

MDR and Article 123 (3) (d) cookies courtesy of Medtech Europe’s Katalin Maté who baked them for a meeting – they were delicious!

Just before the Christmas holidays the Commission updated its rolling plan and the MDCG ongoing guidance overview.

As the year draws to an end, the date of application of the MDR is very close now and I see more and more things happen that everybody could see coming for a long time, I would like to take a few moments to give you my version of Dickens’ Christmas Carol story applied to the MDR and the IVDR. This is – as always – a very personal perspective and although I am a very optimistic person by nature I have found that there is not a lot to be optimistic about with respect to the MDR and IVDR at the moment.

Unless there we have some positive surprises in the months to come of course, of which we have not had that many so far. I have a hard time coming up with examples.

While I’d love to write a positive and uplifting story telling everyone that if they just do their best and apply themselves they can tackle this thing but that would just not be true given the circumstances. We are now at a stage that things are necessarly going to fall by the wayside and collateral damage will occur.

Christmas past – confusion everywhere

Confusion everywhere – the expression we used jokingly to refer to the imperfect but working system. This is the baseline that we came from. The MDR and IVDR were supposed to lead to a more coherent EU devices policy and lead to safer devices with better supported clinical benefits.

We had a regulatory system that was not ideal but that performed really very well for the very limited investments that the Commission and the Member States had to make. Compared to the medicinal products system the medical devices system costs very little to maintain. The market mostly paid for market approval directly via the notified bodies, and Member States invested little in enforcement and market surveillance. Coordination in Brussels was opportunistic: we coordinate interpretation in guidance documents, but will never commit to binding coordination other than under literal text of the directives. This is why we for example had a Borderline and Classification group that could not even agree on what a pharmacological mode of action was, and harmonisation so loosely that the ECJ could come to judgments like Lycocentre. Confusion everywhere – not ideal, but manageable.

Because of fraud with implants (which could just as well have been handled under the old system) and because of a perception that clinical evidence that could be better for implants (equivalency issues that could also have been handled under the old system) we decided to shake up things with new but foremost ‘better’ and ‘stricter’ regulation: enter the MDR and the IVDR. Because we partially blamed the notified bodies (‘they work for manufacturers so cannot be impartial’ ) we wanted all of them re-reviewed to higher standards, even though we could just as well have come to the same result under the old directives (and we largely did already as a result of the joint audits of notified bodies).

We embarked on an implementation trajectory in May 2017 for which the competent authorities and the Commission unfortuantely have little to show today, with six months to go to the end of the transitional period, which takes us from the Christmas past to today: Christmas present.

Christmas present – chaos everywhere

Normally you would enter a transitional period for a radical game changer of regulation with most of the regulations and supporting systems complete: everybody can get used to using the new systems, kinks can be ironed out before everybody must comply and all addressees of the new rules can implement the new rules in their organisations. Makes a lot of sense. This is not the choice that was made for the MDR and the IVDR, probably because of the political momentum that required a fix of a system perceived as broken. The Commission and the Member States embarked on a ambitious implementation calendar for implementing acts, common specifications, guidance and accreditation of notified bodies and then failed to deliver sufficiently for the system to work for all actors involved.

At this moment the Commission seems overwhelmed and has started kicking the can down the road with delaying Eudamed for two years (but not at the same being clear about the consequences) and delaying the need for CE certificates for class I devices that would be in a higher risk class under the MDR via the Corrigendum 2. The Commission now states in the December 2019 update of the Rolling Plan:

“It should be noted that, as a result of the Commission’s obligation to verify under a unique procedure the full functionality of the new database (including all relevant modules), the deployment of a fully functional Eudamed is expected by  mid-2022. The Commission is currently working together with Member States to provide guidance related to how certain new MDR provisions will apply in the absence of Eudamed. In order to support harmonisation during the interim period the Commission intends to deliver the actor registration module by May 2020 on a voluntary basis.”

It also states that the ‘Eudamed is ready’- notice (the article 34 MDR notice) is planned to be published in Q2 2022.

In other words: there will be something of Eudamed in 2020, we don’t know how to work with that and what this will mean. Voluntary use – does that mean that this use can be used later? Actor registration means SRNs, but how will voluntary SRNs work? Can they be converted in mandatory SRNs later? Many Eudamed questions remain, with a lot at stake. But guidance is underway – … OK, nevermind. I would really like to believe that the guidance will arrive on time and will be useful except that we are still waiting for most so much guidance.

The Commission and the Member States started the MDR and IVDR accreditation process for notified bodies later rather than earlier (it was not possible to apply before 26 November 2017, well into the transitional period). I have never understood why this process did not get more priority. It took a long time for the first notified bodies to become available (the first one in the second half of January 2019). During 2019 the Commission kept promising that there would be 20 notified bodies accredited (which includes double counting between the MDR and IVDR, so a notified body accredited under both counts as two for the Commission).

By Christmas 2019 we have 12 (Dekra Netherlands appeared as IVDR notified body in NANDO on 24 December 2019 and MedCert on 25 December 2019). The Commission notes in its Rolling Plan of December 2019:

“Ten notifications completed (8 for MDR and 2 for IVDR). Two more expected before the end of 2019  (1 MDR and 1 IVDR). About 20 designations expected to be completed in the course of Q1 2020. About half of existing certificates are covered by the notified bodies that will have a valid MDR designation in NANDO by the end of the year”

This means we have one more notified body to go this year, if the Commission’s statement is true. All of this would be nice except that it takes notified bodies about 300 days from designation to get to full certification speed. This means that the statement about certificates covered looks nice, but it also means that

  • the other half of the certificates are not covered in time (except insofar they have managed to renew existing (AI)MDD certificates);
  • of those certificates that are covered it is not certain what percentage will receive their certificate in time (300 days ramp up, remember –  almost a year) because an MDR accreditation requires a new review of QMS and technical documentation, so not something that is completed in a few months;
  • the manufacturers that are with a notified body that cannot certify in time have no way to move to another notified body that is either MDR accredited or can still renew an existing (AI)MDD certificate (and takes on new customers because basically none is doing that at the moment)

Even if we have 50% of the certificates covered by notified bodies that applied for MDR in Q1 2020, this is not going to avoid the situation that we will have many manufacturers without certificates by the end of May 2020 for various reasons. In some cases they will have themselves to blame, in some cases they will have been dealt bad cards by the system (e.g. they bet on MDR because their notified body says it will be accredited, then find out that their notified body is either not going to be accredited in time or at all, with no possibility any more to transfer in time). These are the cases that are landing on my desk right now. And there are the cases of the companies with certificates in soft transition – they will be facing the situation of their notified body closing business (three months notice, no other requirements) and having to still apply for an MDR assessment that must be completed before end May 2024. And this is a big wave of manufacturers needing this, because either their notified body or the company itself was not ready for an MDR certification.

Since notified bodies are commercial entities and governed by the market, several things happen now that are typical for sellers’ markets where supply is restricted and demand is greater than supply capacity: prices go up, notified bodies choose their clients carefully and it’s very hard to get commitment to delivery dates. Smaller companies have less bargaining power and I see with some notified bodies that these have even more difficulties in dealing with their notified body.  This system is not designed for surges in load and doing the re-accreditation of notified bodies at the same time as re-evaluation of devices for MDR/IVDR compliance was, certainly with hindsight, not a good idea. The temporary spike in regulatory load requires investments in capacity that cannot be recouped and will likely not be needed after the spike, so will likely not be made. Also, it requires capacity that was never needed, and can therefore not be scaled up just like that. Training enough notified body personnel takes years. In the mean time my reality is that I see more and more companies struggle to have a meaningful connection with a notified body in time to meaningfully meet the deadlines. If you want to change notified body now, prepare to wait until autumn next year. And it’s the small ones that suffer the most because they have the least weight to throw around to secure a scarce slot at a notified body.

Regardless of the notified bodies, if you have an Annex XVI device: good luck getting that certified under the MDR by May 2020 because the Common Specifications have still not been established which means that no-one can even start to evaluate these products, nor is it possible to procedure compliant technical documentation. If you need a notified body for your Annex XVI device, there is literally no way that I see that you can be certified in time. Bad news for the contact lenses for example, or for dermal fillers or for laser hair removal devices.

The fact that there are still no definite harmonised standards for the MDR is perhaps the least of our problems. At least you can declare compliance based on state of art.

Then there is all the remaining guidance promised of which the innovation in the December updated ongoing guidance overview is that the MDCG is now planning to issue it – hold on to your seat – mostly in 2020. When in 2020? Good question. So far the guidance development process was characterised by moving goalposts and known unknowns.

To me this looks like a difficult 2020 with potentially many devices that can not possibly be compliant in time. How will the competent authorities of the Member States deal with this? We don’t know that either. Some have been recruiting, like everywbody else. It will have been a tall order for them to meet their recruitment goals as they are fishing in the pond that everybody else is fishing in too.

Rumour has it that some authoroties are talking about harmonisation of possible exemption policy with respect to companies and products that fail to be compliant in time in. Still, imagine having to request national exemptions in each member state based on different, or only partially harmonised policy, based on different forms. This would be integration reversed. And I did warn on this blog: this is a realistic scenario. And then the question remains whether the national authorities have sufficient staff to handle all these applications in a reasonable time frame? And what criteria will they use? How will they avoid that freeriding is discouraged and what would they like to see in terms of good faith efforts to be compliant in time? If they provide exemptions only for devices that are essential to patient care, that will lead to a impoverishment of the scope of medical devices on the market, and not for the right reasons. Impoverishment and shortages, this is I think what Christmas future may look like, and that’s earlier than you think.

Christmas future – catastrophe everywhere?

Will Christmas future (with Christmas 2020 already as a first Christmas future) be a situation of catastrophy everywhere? I hope not but it might be.

I have seen regulatory changes in the life sciences field turn out very bad, especially for the more innovative SMEs. A case in point that unfolded under my eyes is the ATMP Regulation that was supposed provide better and harmonised regulation for tissue, gene and cell therapy products ended up in impoverishment of the EU biotech medicines industry.  The approval process (which for this regulation was ready in time by the way) turned out to be so complex and expensive that almost no-one company was able to see a new product through to authorisation in an industry that – at the time – was characterised by mainly innovative SMEs. This became so bad that the EMA offered to give additional assistance to companies only to encourage applications on top of its normal SME benefits program, just to have something to show for this regualtory pathway. SMEs in the mean time rather chose to sell themselves to bigger companies as soon as they could, or set up outside the EU. The medical devices industry is even more characterised by many SMEs, and I think we risk the same happening in the medical devices industry.

This SME effect may be strongest in IVDs, where the percentage of companies that will need a notified body is much larger and many of these companies are SMEs with a relatively large number of products compared to the ‘general’ medical devices industry. So we have three IVDR notified bodies now out of a total of 11 applications. There do not seem to have been any additional IVDR notified body applications or we probably would have heard about it. The impoverishment effect could therefore be even stronger in the IVD sector because relatively more work needs to happen with less resources, in an industry that I see not yet generally act like they’ve heard the starting gun.

The same is true for the healthcare institutions, which have obligations too and in my experience are also slow to catch on to those kicking in by end of May 2020.

And there are the class I product manufacturers, that also generally do not seem to have much of a clue what it means to be fully MDR compliant by May 2020. The recently published class I devices guidance does not do a lot to instil a sense of urgency as it does nothing to describe the large gaps between MDD class I and MDR class I requirements.

Independent distributors – same thing: general unawareness.

What will this mean for the patients? I will make a safe prediction: there will not be more innovation, not more availability and not better healthcare because of the stress on the system and the insecurity that goes with it. Hopefully all actors, working together, will be able to avoid that the shortages of devices and difficulties of getting new technology on the market because the system is overloaded and clogged with re-approvals of old devices affect the standard of care too much.

MDR and IVDR goals at risk

In the end, it seems to me that the goals of the MDR and IVDR (“to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation” (recital 1 of the MDR)) are starting to become at risk with the way things are developing, at least for the coming few years. It is starting to become more and more clear that the structures in place and under development are not able to support the change process undertaken at the level we would have wanted.

The policy option chosen at the time (I have reread the original impact assessment for the MDR and the IVDR again) was ‘evolution’ of the then current system.

Evolution by the hand of the blind watchmaker is by necessity a brutal process with a lot of collateral damage, because nature is not a moral theatre. But this is not how we would like to work with a regulatory system for an innovative industry that we should be proud of that is supposed to deliver devices for patients that deserve the best possible care available.

Food for thought. I wish you happy holidays, a good start of the new year and as my late grandmother would wish me: “good luck and wisdom”.

And really hope I will be proven wrong over the next year(s) about this gloomy picture.

More on the PRRC

Schermafbeelding 2019-12-07 om 18.03.19.pngI have written about the PRRC before, when the MDCG PRRC guidelines came out earlier this year.

With more experience with the subject in the mean time and everybody working to understand the subject, I thought it was a good idea to revisit the subject. And another good reason was that I had to look into it again because of the presentation I did at the Q1 EU Medical Devices & Diagnostic Quality Management Conference in Frankfurt last week. If you were not there, you’ve missed a good conference with among other things interesting exchange of experiences on how the first notified body QMS audits have been and how to work with the economic operator requirements in your QMS.

Surveillance interest in PRRC implementation

Below is my contribution to the MDR and IVDR QMS discussion, regarding the PRRC. Interestingly experience with QMS audits for the MDR shows that notified bodies take a lot of interest in the PRRC and the way that function is embedded in the manufacturer’s QMS. I have heard that competent authorities see the PRRC as an important compliance promoting factor and that they have instructed notified bodies to pay specific attention to it. Thus, it is clear that everyone on the suveillance side expects a lot from the PRRC and wants to see manufacturers take this position seriously, which should be reflected in the way the position is implemented in the QMS.

PRRC = sort of DPO

I have personally found that one of the better models to use for implementation of the PRRC may actually not be the pharma QP/QPPV but rather the General Data Protection Regulation’s Data Protection Officer. The way that the GDPR provides that the DPO must be implemented in a company shows a lot of parallels with what the authorities seem to have in mind for the PRRC under the MDR and IVDR. Especially the connection between management and the DPO has created a lot of positive and much needed awareness in data processing companies. This is – in my view – what the authorities are looking for with the PRRC as well: an increase in compliance awareness culture.

Curious about the more detailed version? Take a look right here:

PRRC guidance to be ‘updated’

Interesting news is that the not super well drafted PRRC Guidance of the MDCG is now slated to be updated somewhere next year, according to the Commission’s rolling guidance forecast. We know by now how much timing is worth when it comes to development of guidance, so it may also be later. It shows in any event that the MDCG has realised that the guidance needs revision.Schermafbeelding 2019-12-07 om 17.56.55.png

Work in progress

The PRRC is a work in progress, but nothing prevents companies to implement it as best as they can already. Be prepared to implement the PRRC as something more as a token function, because this is not what the notified bodies and authorities seem to be looking for.

 

The Commission and the Council on the MDR state of affairs

logo.pngThe public part of the Employment, Social Policy, Health and Consumer Affairs Council meeting on last Monday, 9 December 2019 gave an interesting peek into how the Commission and the Council see the state of affairs with the MDR and IVDR implementation at the moment, and notably as well the delay of Eudamed implementation. The Commission was asked to provide an update of affairs to the Council, which was visibly ruffled and concerned about how the implementation of the MDR and IVDR were progressing. If you’re interested, you can watch it via this link.

So what’s the news? In case you are not curious enough to sit through the whole meeting, here is my summary.

Commission: ‘it will be bumpy’

12 notified bodies, not 20.jpgThe Commission, represented by the commissioner for health Stella Kyriakides herself, started off by mentioning the 20 notified bodies that it had been promising for this year actually turn out to be 12, which will include the double counted ones for the IVDR (that’s not what the Commission said, but that it how the Commission has been counting them so far). This means three additional notified bodies this year, but no mentioning of the way this works with the double count. I suspect that Dekra Netherlands is in the pipeline and one of these three. Rumor has it that NSAI may be another one. The other one could well an IVDR notified body. But, the Commission said, we will have 20 notified bodies by Q1 2020. By now I am quite tempted to say that seeing is believing.

The Commission further announced that Eudamed’s delay did not mean that the MDR will be delayed, like I mentioned already. If you did not believe me so far, maybe you will believe the Commission. If you believed the Commission when they said it would be 20 notified bodies this year – wait a second…. anyway. The Commission mentioned that it has started on the operational details of non-Eudamed information exchange as required under the MDR when Eudamed is not ready for some reason of the other, just as the ‘what if Eudamed is not ready’ regime in the MDR prescribes. So, the ‘Eudamed without Eudamed structure’, if you will, is under construction as we speak and there seems to be a central plan behind it. This is tentative good news in an otherwise not so good situation.

But, the Commission is looking into making the actor registration module available to the market on a voluntary basis by May 2020, seemingly in an attempt to help the market prepare for Eudamed going fully live at some point. This would seem to allow the economic actors to register themselves on a voluntary basis, but not yet their devices (because that is another Eudamed module).

After all the Member States had spoken as Council members (see below) the Commission finished by stating that the MDR was happening by end of May – Eudamed not being available was foreseen, so the MDR could go ahead without alternative plan. So, for the people that still do not believe it: no delay of the MDR. The Commissioner repeated this commitment in the press conference afterwards, and made the epic understatement that it would be a bumpy road to end of May 2020. I’m sure we all agree with this.

Council: ‘speed this thing up’

The Member States in the Council seemed somewhat exasperated and mostly echoed Sweden and Ireland in that the Commission should really intensify its efforts, provide a readiness check early 2020 and set up a dedicated MDCG group to deal with this and keep the Member States informed better. Clearly the Member States are not very happy with the way things are going although this was not what they admitted during the press conference afterwards. In the press conference afterwards the Finnish Presidency did not answer the question of a journalist who asked what the readiness check would look like. The Commissioner did not commit to this either and just said the Commission would keep the Member States informed.

Almost every Member State expressed concerns about the Eudamed delay, and here it was also interesting what was mostly not said and what the German delegate did say: Member States are worried about the level at which the Commission is doing Eudamed by itself and does not involve them to the level they would like. This confirms what I have heard earlier: that the Eudamed delay was also a surprise for the Member States because they were not that well informed. Some Member States (Hungary and Estonia) stated how this interfered with their national implementation process.

Other Member States stated other concerns that you would expect: why are there not enough notified bodies, why are the implementing acts still not there, where are the Common Specifications for reprocessing and Annex XVI devices.

The Netherlands, pragmatic as always, was advocating that parts of Eudamed should be adopted immediately when they were ready. Pragmatic, sure – but not how the MDR works. So those modules could, at best, be made available on a voluntary basis because still nobody want to re-open the legislative procedure for actual changes to the MDR. It would be a possible help for the companies that otherwise would need to find a way to be able to store and make available later into Eudamed two years worth of MDR related data and reports.

Bumpy road

As the Commissioner said in the press conference: it will be a bumpy road. Let’s just hope it gets us there.

Corrigendum 2 and the (potential) consequences for class I devices

Schermafbeelding 2019-12-08 om 17.43.09.pngEverybody has been in enormous suspense about how the second corrigendum to the MDR and IVDR would turn out. The version that came out of the European Parliament’s ENVI committee vote contains a number of very technical points that I will not elaborate on. But it also contains the big break for certain class I devices, the ones that are either up-classified under the MDR (and need a CE certificate under the MDR as a result) and the re-usable surgical instruments (which need a CE certificate for the reusability aspects under the MDR).

At this moment, the corrigendum has not been finally approved. This is supposed to happen somewhere before Christmas, so the class I devices industry may get a nice Christmas present under the tree – or not. If the corrigendum is still shot down on the finish line, this will be too bad as most of the class I devices that are unclassified under the MDR will likely not be able to find a notified body in time and will need to temporarily or permanently leave the market.

Class I MDR only, not IVDR

It concerns MDR devices only? Yes, this corrigendum does not contain any provisions with regard to up-classified IVDs, which comprises basically 85% of all IVDs currently on the market. This is why IVD manufacturers should still go full speed ahead with their IVDR implementation. I think it is unlikley that there will be a change in transitional regime for this large a group under the IVDR, because that would essentially change the nature of the transitional regime. But what do I know? It might still happen if the bottleneck for the IVDR is as severe as I predicted.

In the below presentation I have set out the consequences for class I devices of the corrigendum as I see them currently. I explain them in person in a lot more detail on the Medical Device Made Easy podcast about this exact subject (this is the first part of two parts about class I devices and the MDR, next one to follow later). I recommend that you follow this podcast for everything MDR and IVDr related, because like this blog that series of podcasts is starting to form a very nice body of knowledge and training material on EU devices regulation under the MDR and IVDR and provides a lot of expert knowledge on it. And it is very very practical.

The corrigendum creates two classes of class I devices:

  • the ones subject to the corrigendum and thus included in the article 120 (3) and (4) MDR regime; and
  • the ones for which it is business as usual and that must meet the full MDR requirements by the date of application (26 May 2020).

Subject to corrigendum devices (“upclassifieds”)

schermafbeelding-2019-12-08-om-19.12.34.png
The class I devices subject to the corrigendum are all devices that are up-classified under the MDR under Annex VIII, notably software (rule 11), devices with nanomaterial (rule 19), inhalers (rule 20) and substance based devices (rule 21) and the re-usable surgical instruments. These devices are subject to the transitional regimes in article 120 (3) and (4) MDR provided that they have a valid declaration of conformity before 26 May 2020. They can then

  • Be placed on the market under that declaration of conformity until 26 May 2024 – provided that there is no signficant change to intended purpose or design (more about significant changes below); and
  • Be sold to end users until 27 May 2025 (so the devices placed on the market before 26 may 2024 have another year to make their way to the end user).

And they must be covered by an MDR CE certificate that a notified body must issue by 26 May 2024, in order to continue to be placed on the market after that date.

See in the embedded presentation above what these devices must do under article 120 (3) MDR, and all of that is minus Eudamed for the moment.

Word of advice: some clients of mine in this boat are already saying “Yay! We can postpone our CE certification for the MDR until 2024!” and I am telling them “No, unless you change the name of your MDR project into Project Kamikaze and put a note in your calendar for 1 April 2024 saying ‘Erik told us in 2019 that this would be a bad idea and now we owe him a bottle of good champagne.’.”.

Why is it a bad idea? By the end of the article 120 (3) MDR  soft transition period everybody and their mother, the extended family and all cousins too need a CE certificate as well. Not only will there be the normal MDR certificates demand at the level of normal market conditions, but also all AIDD and MDD certified devices that need MDR certificates by then. And the difference is: these manufacturers will already be existing customers of the notified bodies, so they will go first and even for them it is not sure that there will be enough notified body capacity by then. So if you wait until the end of the transition period you will be lucky if a notified body will even pick up the phone by then to tell you that they are not accepting new customers. Better plan your inevitable transition to an MDR certificate way before 2024, preferably 2021 or 2022 as this will likely be a less busy period. Planning it at the last moment possible is a recipe for trouble – you’ll have no one to blame except yourself when you wait until the last moment to find out that all the notified body capacity is spoken for. I will quote you Kant, one of my favorite philosophers: “Sapere Aude” (‘dare to be wise’).

Signifcant change

The significant change under article 120 (3) MDR is kind of a landmine of a concept that can really mess things up for you as a class I manufacturer. That’s why it is really important to know what a significant change is. Fortunately there is guidance on the way! Oh, wait…:

Schermafbeelding 2019-12-08 om 17.46.12.png

Yes, you are seeing this right. In the last version of the ongoing guidance development document the task force for this (the concept has somewhat of a sense of urgency to it) still had to be set up and planned release is TBD. How is that for a sense of urgency?

The consequence of a significant change is that your declaration of conformity will not be valid for the article 120 (3) regime anymore, which means your CE mark is instantly invalid, causing non compliance for every every next device that you place on the market.

But things can be even worse if the significant change affects the installed base of devices already at customers. A totally non-hypothetical scenario that I am sure will happen is that of a software update to a manufacturer’s software installed in hospitals turns out to be a significant change, e.g. because it is a line extension of the installed software, adding addition convenient functionality or is a fundamental redesign for the software to be able to run on 64 bit operating systems too. Especially in the last case the IT department may roll-out the update without thinking because nothing changes. In both cases releasing the update will constitute a significant change. In order to help you decide if a change to software is a significant change LNE/G-MED’s guidance on significant change has a helpful flowchart (no 5) in it for software. The guidance has other helpful flowcharts too. But, this is what LNE/G-MED thinks, and as class I device manufacturer you are dealing with competent authorities and not with notified bodies.

Full MDR by 26 May 2020 devices

Schermafbeelding 2019-12-08 om 19.12.19The devices that are not subject to the corrigendum are going to have to be fully compliant by 26 May 2020. These device are subject to the full MDR (minus Eudamed for the moment).

This is a big step up for class I device manufacturers that have been operating under an MDD Annex VII QMS, because they are going to an ISO 13485:2016 plus QMS. Also, these manufacturers will run into the alternative meanings of CE and MDR: Clinical Evidence and More Data Really. You will not only need to redo all of your clinical evaluations, but you will need more data as input (which you will likely not have if you have not been doing active post market surveillance as many class I manufacturers have not been doing).

The above presentation provides an overview of what you can expect as a class I device manufacturer under the MDR. If you start to figure all of this out only now, you will have a very steep learning curve and a lot to do in very little time.

Suspense suspense

We’ll have to see if the corrigendum 2 is a done deal or not. If it is, it temporarily solves the predicament of the class I devices that are unclassified or need a reusability certificate under the MDR. But, it’s just kicking the can down the road – don’t forget that these devices need an MDR certificate by 26 May 2024, so better start with that sooner rather than later. And all the other class I devices: be prepared – you’re on for 26 May 2020.

Eudamed delayed, but MDR not delayed – now what?

Eudamed scream catYou may have already heard it from many directions: Eudamed is delayed with two years.

Time to party now because you can shelve your MDR implementation project for two years and go back to do other things? Nope, unfortunately most probably not – read on.

After some pretty mysterious statements of Commission officials in public around the end of October 2019 to the effect that the first tranche of Eudamed might perhaps not be ready to be launched in March 2020 suddenly the text of the Commission information page on Eudamed was changed with the following little block of text:

“The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore EUDAMED’s launch will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices i.e. May 2022.

The date of application of the MDR remains May 2020.”

What does that mean? What follows below is my own analysis from the situation that I could not validate from official sources other than the MDR text itself and the CAMD MDR FAQ. And I have heard a lot of different interpretations and speculation of course.

Eudamed is delayed but the MDR is not

First and foremost it means that only Eudamed is delayed, but not the rest of the MDR. The Commission literally says on the website: the date of application of the MDR remains May 2020. It seems that it would not follow from the fact that you cannot upload documentation that the MDR requires does not mean that you shouldn’t prepare them as of the date of application of the MDR. In the CAMD MDR FAQ the member states say:

“The different Articles listed in Art. 123 para 3 d (= dealing with e.g. the registration of devices and economic operators, clinical investigations, notified bodies, vigilance, post-market surveillance, market surveillance) are not fully postponed with regard to their application but generally remain applicable from the DoA. However, their application is postponed as far as the obligations and requirements within these Articles relate to EUDAMED (which is not fully functional yet). To that extent they shall apply from the date corresponding to 6 months after the date of notice of full functionality.
Meanwhile (until EUDAMED is fully functional) the corresponding provisions of the Directives regarding exchange of information continue to apply.
The principle is that the derogation applies to the electronic exchange of information/upload to EUDAMED. If the derogation is applicable this does not necessarily mean that the information itself does not need to be prepared/exchanged. This exchange of information e.g. reports will have to be done by other means in lieu of exchange via EUDAMED (Directives regime). The underlying idea behind this paragraph was to ensure compliance with the new obligations and requirements via the “old” systems as far as possible.”

(underlining added – “not necessarily not” is a key concept here , because this means that it may also be decided / interpreted differently at a later stage)

and of course

“The actual practical implication of this concept with regard to the different Articles listed in Art. 123 para 3 d MDR needs a closer look and further guidance, which is in progress.”

Yay! CAMD to the rescue – guidance is coming! Oh, hang on … If we look in the rolling guidance plan it says: “Eudamed Group yet to be established under MDCG, ongoing work falls under the scope of the Eudamed implementation Steering Committee”. That’s a hopeful sign of guidance coming soon.

Let this sink in, in case you or your colleagues have let out a sigh of relief, you maybe have done a little departmental celebratory line dance to celebrate that the pressure is off and this whole MDR thing has been moved two years into the future, because it has not been. So, get your colleagues off of the hands that they may have immediately been starting to sit on again, safeguard your budgets that management may have immediately cut: this MDR thing is happening, even if Eudamed is not happening yet. If your management thinks delay means nothing is happening anymore, slam their fingers in a door while yelling “NO DELAY OF MDR!!!” to condition them to the inevitable reality that they keep forgetting. Reporting and registration into Eudamed is delayed, the other things are not and they might need to go elsewhere for the moment.

The MDR even makes provision for the situation that Eudamed might not be ready (see article 123 (3) (d) MDR about the ‘unforeseen circumstances’ that by now were totally foreseen but that’s another story), so it is happening, Eudamed or not. It may not be happening as smoothly as envisaged (I guarantee you that it will not) but the date of application for the MDR does not change. In case anyone in your organisation thinks otherwise: they are wrong and are putting your company at risk.

Why no phased introduction anymore?

It means that the Commission seems to have understood how the MDR works regarding Eudamed, and that it is not possible to say that Eudamed is ready when in fact only the first stage is ready and other stages are to follow, as they were planning when it became clear that Eudamed would not be available fully in time. Perhaps the Commission’s Legal Service has woken up somehow and decided that you cannot declare something that is completely ready when only a slice of it is ready, who knows. Article 34 (2) MDR is pretty clear that Eudamed can only be declared ready based on an independent audit that full functionality has been achieved. Even legal interpretation of rules has its limits.

So what happens now / article 123 (3) (d) and the art of non-Eudamed application

What happens now is that the MDR enters into force exactly as planned (don’t tell me I haven’t been warning you for several years that there would not be a moving of deadlines), but without Eudamed and the MDR provisions regarding the possible situation that Eudamed would not be ready in time (which were always there from the start and which I have been warning companies about for quite some years in the mean time as well) will be applicable – I present to you the staggeringly complex article 123 (3) MDR. These provisions are (unfortunately) not very well written nor easy to distil a very clear set of manufacturer obligations from. In the following I have tried to do some distilling for you. This is my best effort at this moment because a lot of things are unclear. You would almost wish that the Commission would provide timely guidance on the subject (oh… never mind).

I think it’s relatively safe summarize as follows:

  • Delay of Eudamed does not mean that the MDR is off the table for the moment (so obvious I’m not explaining this further);
  • Delay of Eudamed does not mean that preparation for Eudamed can stop;
  • Eudamed will still be implemented at some point because the MDR and IVDR cannot function very well without it;
  • You better find a way to track and keep data that should have been going into Eudamed from the start because it is likely that you’ll need to upload it retrospectively when Eudamed goes live and you need to find a way to provide it to the right member state authority (unless we hear differently when the we hear if there are any exceptions to the principle that “this does not necessarily mean that the information itself does not need to be prepared/exchanged”.

So, Confusion Everywhere anyone? Or rather Chaos Everywhere? I’m not sure which one it is these days.

Delay of Eudamed does not mean preparation can stop

The delay of Eudamed does not not mean that preparation can stop for the moment, because reporting and registration into Eudamed is delayed, while all the other things are not. Did I say all things other than registration and reporting into Eudamed are not delayed? That’s because they are not unless we hear differently in specific cases (which we have not for the moment).

This means that the underlying MDR related obligations that lead to reportable and registrable documents still apply.

So you cannot stop work on Eudamed preparation. In fact, you will likely need to step up preparation work. Let me explain why:

The delay results in you having to do multiple things at the same time now:

  • first, continue developing the Eudamed interface for your company and getting your device data ready for being uploaded into Eudamed, especially if it’s a machine to machine interface;
  • secondly, ensure that device data that is MDR relevant and that is created after the date of application (26 May 2020) is reported under the old regime insofar required (article 123 (3) (d) MDR) but also is put in a Eudamed ready format so it can be uploaded into Eudamed when Eudamed becomes available because you will likely have to do that. It means keeping track of everything that should have gone into Eudamed from the start until Eudamed goes live, so including vigilance data, device iterations, all that (and will be data for two years!!). This will be a big IT challenge.  You have to create a spreadsheet or database that approximates expected Eudamed specifications as close as possible so you can upload the data at some point, which will still be a huge job; and
  • thirdly, deal with any new national Eudamed like initiatives that member states may maintain or make mandatory pending Eudamed’s delay.

And in addition, you need to do MDR with (AI)MDD tools:

Delay of Eudamed means that existing systems must be kept operational longer

Delay of Eudamed means that you need to report MDR using (AI)MDD systems available at the member states. Sounds like a square peg in a round hole situation? I’m sure it will be like that. Member states may change things around as well as they are preparing too for Eudamed, or maybe lose trust in the project altogether. Quite a few member states have decided that they wanted to run parallel databases of their own and see their decision to do so strengthened by the developments, because patient safety waits for no one. So be prepared to (continue to) work with a variety of non-standardised member state situations, because this was exactly what Eudamed was supposed to fix.

Eudamed for IVDs

So you would think: ah, but for IVDs this is not an issue. Because Eudamed is happening when the IVDR happens. Pfew! Well, maybe think about this in more detail. Article 30 of the IVDR that deals with Eudamed operates on the assumption that Eudamed is already up and running by the time that the IVDR becomes applicable. This means that all Eudamed obligations under the IVDR become applicable simultaneously with (as things are looking now) the date that Eudamed is launched, because the IVDR’s ‘Eudamed is not ready’ regime in article 113 (3) (f) only applies when Eudamed is not fully functional by the date of application of the IVDR. This will also be the date on which the whole rest of the medical devices industry will be uploading their two years worth of data into Eudamed – as things are looking now. This cannot possibly go wrong, right? Scenario anyone?

The sad reality of it

The sad reality of this situation that all of this has the potential to become a total train wreck of unclarity. I have urged companies before to make scenarios for contingent situations. Brexit, Swixit, etc. This is also one of those contingent situations – article 123 (3) was in the MDR since May 2017. Did you not have a “Eudamed is not up yet” scenario? Better start working on it and think about improving your QMS’ ability to deal with regulatory contingencies.

Pending guidance from the Commission nobody has all the final answers, and there are diverging interpretations of what the Eudamed delay will mean. The above is my best interpretation based on the materials I have available and the time I’ve had to dedicate to figure this out. There are different interpretations than mine around, and mine might even be wrong. Of course I will write more about the Eudamed delay on this blog as things develop and hopefully become more clear. The ball for that is very much in the Commission’s court and I hear that guidance is under development.

But doing nothing is always a bad idea under all circumstances. Just ask the hedgehog crossing the road and rolling up when a car comes. So get in gear and stay ahead of this thing as much as you can.

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