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.