MDR and IVDR outlook for 2023
What to expect for the MDR and IVDR in 2023? Predictions are very hard, especially if they are about the future. That’s a paraphrase of a very solid Danish nugget of wisdom attributed to the physicist and chemist Nils Bohr. But let’s see what we can do based on some basic extrapolation of things currently hanging in the air that I will discuss below in this blog.
I know that I have not been very positive about the MDR in 2022. In fact I’ve said that we are in a process of Verelendung with this regulation at the moment in which things first need to get worse before they can get better. I think this was not exaggerated at the time and still may not be at this moment. I also think that the IVDR is an accident waiting to happen in much the same way as the MDR, because all the same mistakes are being made, and some additional ones.
But … something is slowly starting to be done – actions are being taken with the intention to fix these problems.
Commission proposal to amend MDR transitional regime
After the Commission’s very generally worded outlines of a potential proposal presented on the 9 December 2022 EPSCO meeting I was personally amazed by quite a number of consultants calling this ‘an official proposal’ and some stating that MDD certificates would be ‘extended’, for both of which there was absolutely no (legal) basis whatsoever. This is unfortunate because this regulatory gun jumping does not help to make things clearer and only creates confusion – it’s always better to be correct than to be first when it comes to these things I would think.
The outlines of the potential proposal still leave a lot of gaps, as I have discussed on this blog earlier. We will need to see if the Commission actually makes a proposal early January as announced at the 9 December EPSCO meeting. The Commission has said it will so it is likely, but we also expected the proposal way earlier (on 9 December 2022) and ended up disappointed – the Commission can always still postpone it. We have also seen the Commission moving the Eudamed deadlines again and again and postpone the necessary measures for Annex XVI devices for years. Then we will still need to see what this proposal will look like exactly. Will it also revive MDD certificates that have already expired and under what circumstances? Will it extend the My 2024 end of grace period back stop date? How will it relate to the Article 97 MDR ‘bridging solution’ set out in MDCG 2022-18 (discussed below)? This is important because Article 97 MDR is only needed where the law, the MDR, does not provide for a solution allowing the manufacturer to be compliant for the device concerned. For example, if a change to article 120 (2) MDR for example extends the duration of certificates for legacy devices (which is a possibility according to the Commission), then less Article 97 MDR applications will have to be made, which would free up valuable competent authority capacity.
After it has been made the proposal then needs to go through the EU legislative procedure during which it may still be amended, so I expect nothing definite before end of March 2023 (and that is if they really speed up the legislative procedure, which may not happen because some Parliamentarians have indicated that they want to give this proper consideration and will not be rushed like last time with the MDR date of application move from 26 May 2020 to 26 may 2021).
So hold your horses when you say that the MDR transition period will be extended and that there is an official proposal but please wait for the moment that we really know what this will look like before making specific claims about the future of the MDR transitional regime. Plan for notified bodies waiting with any definite steps until the legislative proposal is actually law (not before March 2023 likely).
There may be more in the proposal that was not discussed yet in the Commission’s briefing note for the EPSCO meeting.
Article 97 MDR – the silver bullet bridging measure?
Right after the EPSCO meeting MDCG 2022-18 dropped, the bridging measure that the Commission referred to. ‘Bridging measure’ has a degree of optimism to its name right? We go from one place to the other where we were unable to do so before, and when we get to the other place we will be where we want to be.
The question is how much the Article 97 MDR option is going to help patients and industry. The problem is that the Article 97 MDR process is most likely understaffed at competent authorities, which means that there will be – again – significant congestion in the system. A telling sign of how well all of this is under control is that the Dutch competent authority IGJ put up a webpage with a huge ‘article 97 guidance for NL coming soon’ cliffhanger some time after MDCG 2022-18 was published. You might think that a clear pathway for these applications would be a matter of urgency and that competent authorities when working on MDCG 2022-18 in the MDCG would have seen this coming and had their local pathways ready – apparently not. But, the Commission proposal (discussed above) may still influence things on this point.
As I have discussed, MDCG 2022-18 leaves a lot of open points (e.g. as regards SMEs and MDD certificates that have already expired) and therefore lots of potential for national divergence. In this regard it is unfortunate that the choice was made for an MDCG document and not for an implementing act under Article 97 (3) MDR, because this leads to less responsibility and more potential divergence – and l 024-mdr-danger-zone-and-outlines-of-a-potential-solution-in-mdcg-2022-11/]). This is the bridging aspect.
The MDCG 2022-18 position paper in its newest version (it has been changed without notice or version control after the initial making available for download on 9 December) contains an annex with a checklist of what to submit for an Article 97 (1) exemption. And now let’s hope that the competent authorities have sufficient headcount available to process these applications in a timely manner.
IVDR – a similar disaster in slow motion
If there is one thing clear it is that the IVD industry seems to have learned absolutely nothing from the dire situation of manufacturers under the MDR that was caused by going all in on maximum use of the grace period and waiting until the very last day of the transitional regime with MDR conformity assessment applications (all these 26 May 2024 certificates that led to many manufacturers also kicking the can down the road as far as possible and starting conformity assessment too late – aggravated by notified bodies not being available). IVD manufacturers seem to be doing exactly the same now after the early 2022 change to the IVDR grace periods. The capacity problem is different for the IVDR however, at least at the moment: beginning 2022 the transitional regime for the IVDR has been changed as to implement staggered grace periods for different risk classes and by the end of 2022 the number of IVDR conformity assessment applications had dropped to the point that even the few notified bodies notified for the IVDR start to publicly advertise available slots for conformity assessment.
An important element of the IVDR is assessment of class D devices by reference laboratories. Do we have any? No, not yet. We do have the Commission asking member state laboratories if they would please consider applying for a designation as reference laboratory. The Commission published a fancy document with all the advantages, which hopefully will convince some laboratories to apply. This process is about two years overdue.
Another problem under the IVDR is the widespread resistance of health institution laboratories against compliance with the in-house produced devices regime under article 5 (5) IVDR. MDCG guidance on the in-house produced devices regime is still – as it has been for a very long time – forthcoming. I see also a reluctance on the part of market surveillance authorities to act against non-compliance by health institutions after the first parts of Article 5 (5) IVDR became applicable on 26 May 2022, which they should take care to not see lead to discriminatory market surveillance between CE marked devices and in-house produced devices. In the end, the GSPRs apply to fully to all devices that are deployed clinically on patients outside performance study, regardless of where the device is developed. Of course it does not help here that the MDCG guidance for in-house produced devices still has not been issued, making it hard for competent authorities to enforce and for health institutions to comply.
Roll-out of MDCG 2022-14 actions
The roll-out of the 19 measures to free up notified body capacity and to make the process of conformity assessment run more efficiently as set out in MDCG 2022-14 is underway and will – let’s hope so – continue to be underway for 2023. I have been somewhat critical about the contribution that the measures are going to make to solving the problems, but I think that the most important benefit of MDCG 2022-14 is that the MDCG realizes that the system is not working and that the member states and MDCG have a role to play to be part of the solution rather than of the problem – this is progress. While some measures (according to the Commission) do not need to be implemented and some are underway, the Commission states that it is
“important that the MDCG, with the support of the Commission, pursue its work to implement also the remaining actions”.Information note from the Commission for the EPSCO meeting
Indeed, that’s an understatement. Member states in the MDCG for example totally control themselves whether medicines agencies of the member states cooperate sufficiently in the conformity assessment of combination products (point 19 of MDCG 2022-14). It is vital that the MDCG and respective member states continue to be part of the solution rather than of the problem by implementing not only the 19 MDCG 2022-14 points, but also more generally be the best authorities and coordinating body that they can be. Let’s not forget that behind every device that does not make it to market or that has to be withdrawn from the market due to certification issues there are patients that may not get the medical care they need or to the standards we pride ourselves on in Europe.
To make this very concrete and specific: for me this is as critical that my family members that are dependent on pacemakers and ICDs will likely not receive the latest model with the latest algorithms available if they are up for a replacement in the near future, and will literally be missing out on medical innovation and potential increase in standard of care that can benefit them for a better outcome. And all of this only because of bad legislative choices, an understaffed notified body re-notification process and a generally badly managed transition period. And the worst is that these choices were made to solve a problem (fraud) that you cannot solve this way, because the MDR and IVDR can in no way prevent a manufacturer intent on committing fraud to do so.
However, the other stakeholders have a role to play in making the system function as well.
Notified bodies have a role to play in the roll-out of MDCG 2022-14. I see increasingly erratic behavior around planning of assessments and audits, making it absolutely impossible for manufacturers to predict the time of conformity assessment. In addition, I see notified bodies offer red carpet conformity assessment programs that they sometimes really fail to deliver on. The tragedy there is also that SMEs generally cannot even afford these premium programs. Some of the decisions I see notified bodies take would really be at odds with principles of good administration (such as sometimes making very impactful and costly (for the manufacturer) clerical errors and for some reason not being able to correct them immediately), by which the competent authorities are bound (Article 99 MDR / Article 94 IVDR). It appears that notified bodies do not always seem aware of the fact that they are exercising delegated state authority concerning market access, the exercise of which should be subject to good administrative practice. In that regard it remains forever puzzling to me as a lawyer why Annex VII, 4.8 on decisions and certifications only describes that the procedures should be documented but not that they should be applied in accordance with the principles of good administrative practice, which is the very least you would expect if delegated state authority is applied. ISO 17021:2015 does not provide for this either, describing only a need for documented procedures but not for good administrative practice. And don’t get me started about the possibilities of legal review / appeal of notified body decisions. In that respect it would be useful to do the thought experiment discussed below: what if the government agency for medicines marketing authorizations would act that way? And you would have no viable means to challenge that in court? Would that be acceptable?
Finally, manufacturers do not always put in their best effort either. Regulatory departments may be under-resourced (because it only concerns market access of core business, so why would that be important), are sometimes undertrained (leading to sub-standard conformity assessment applications that do not make it to validation and actual start of the assessment) or management decides to postpone submissions for MDR or IVDR conformity assessment because ‘there still is time’. Not a good idea at this time for the Union market.
Thought experiment with medicines regulation
EU pharmaceutical law is currently up for a major revision, and it is my firm expectation that this will somehow be managed a lot better than the MDR and IVDR legislative changes. For the life of me I cannot understand why we accept such stunning underperformance of the EU regulatory system for medical devices. In discussions I often invite people to do the thought experiment: “What if this happened in pharmaceutical products regulation?”. Usually the sad answer is: nobody would accept this and the world would be too small to fit all the outrage in.
Maybe it would be good for the MDCG, the Commission and the member states to do this thought experiment, it might give them a bit more of a sense of urgency and purpose. Member states and the Commission might provide more resources to make the medical devices regulatory system work.
Rolling Plan and ‘planned’ guidance
According to the Rolling Plan we have several things to look forward to in 2023:
- an implementing act on designation of EU reference labs for the IVDR (possible as of 2020, better late than never),
- entry into force of Commission Delegated Regulations amending Regulation (EU) 2017/745 and Regulation (EU) 2017/746 as regards the frequency of complete re-assessments of notified bodies (one of the actions from MDCG 2022-14),
- updated harmonised standards (now that would be nice and very much needed), and
- a Commission Delegated Regulation on UDI assignment criteria for highly individualised devices (contact lenses).
In terms of MDCG guidance under development it’s kind of remarkable that no guidance whatsoever has been slated for 2023. I guess this means that we might interpret this as that all the guidance that was slated for 2022 but was not delivered will be delivered in 2023? That’s a bit of a cheeky statement because literally every MDCG guidance document announced but not yet delivered yet was slated to be delivered in 2022. So we’ll need to see how this goes, the MDCG being the MDCG, sometimes taking years for a guidance document.
Time to restore trust in the EU medical devices regulatory system in 2023
I think that 2023 will be the year in which the MDR will need to prove that the regulation (and especially market access component since legacy devices are not grandfathered) is fit for purpose and in which the EU must restore trust in the EU medical devices market access system, because I see all around me that it is at an all time low. For that we need a Commission proposal in January that works, competent authorities providing a reliable and quick article 97 MDR pathway that works and further roll-out of the MDCG 2022-14 points is needed. And these three things need to work together well.
Already many large and small companies have gotten quite disillusioned and are moving away from an ‘EU first’ market access strategy. It may take years to regain this trust, but 2023 is the year in which the trend of trust will either slowly start to climb up again or will plummet further.
For the IVDR the main issue will be to avoid that the same mistakes as under the MDR are made, perpetuating the same problems and leading to the same problems as under the MDR. Also industry has a role to play there, by utilizing the available notified body capacity as much as possible and not adopting a waiting and seeing approach. And notified bodies can help by being ideal wielders of delegated state authority.
So happy new year my dear readers! Let’s cross our fingers for 2023 (especially if you’re a patient in the Union dependent on medical technology) and let’s all do our best to be part of the solution rather than of the problem. Because in the end the actual health of actual people depends on it.
And don’t forget that there is a book that contains all (well… a lot anyway) of the answers 🙂