Today is the day that the amendment, aka the ‘extension’, to the MDR enters into force because it was published in the EU’s Official Journal today, number L080. As you are reading this, the amendment now applies all throughout the Union as referenced in article 1 MDR and IVDR. Union as in not European Union, which is something different. This is one of the most often made mistakes in relation to the application of the MDR and IVDR: people (among which even the MDCG in some cases, such in as MDCG 2019-7 regarding the PRRC) referring to the geographic scope of application of the MDR and IVDR as EU, and completely ignoring that this is not even what the MDR and IVDR say, what the EEA Agreement provides (it extends the scope of the EU internal market to Norway, Iceland and Liechtenstein) and what the EU’s Customs Union with Turkey provides (extends the MDR and IVDR to Turkey). Anyway, fortunately this MDCG PRRC document is up for revision in Q2 2023. Let’s hope the good members of the MDCG address this in the future, because if I were the Turks, Icelanders, Liechtensteiners and Norwegians I would not be happy with structurally being mistakenly kept out of the Union for the MDR and IVDR, even by the MDCG.
Asking about the MDR or IVDR ’s geographic scope is a good test to determine if regulatory people really understand the subject matter. Because if you think it’s limited to the EU only, you are missing countries where the MDR and IVDR apply, and some pretty major ones at that (like Turkey). If you want to know also in exactly which overseas territories of these Union member states or exotic corners of Europe like Svalbard (also known as Spitsbergen) or the Holy See the MDR and IVDR apply and do not apply, check out the 2nd edition of my book, The Enriched MDR and IVDR. But Erik, you’re always such a nitpicker you might retort. Well, here’s a thought experiment: if you’re a US company (who often get this Union thing wrong), would you hire someone for US work that keeps insisting that FDA law does not apply in, say, the state of Washington? Or California? Or Hawaii?
But I digress on technicalities. You want to know about the amendment of course!
Let’s not forget that the amendment does not only concern the MDR, but also the IVDR, as it removes the sell-off periods for each of the IVDR’s grace periods. More about that below under Sell-off periods.
How does the amendment work? Anything new?
Well, it works exactly as I’ve already described in a previous blog post, since the text has not been changed at all during the legislative process. So it’s exactly the same as proposed on 6 January last. I hope you used that time well by preparing rather than waiting if something might still change because in the latter case you’ve been wasting precious time.
Still, here is a summary:
(1) Extension of the MDR transition period until 31 December 2027 and until and 31 December 2028 depending on the device’s risk class to be determined in accordance with the MDR classification rules. The extension is subject to several conditions to ensure that only safe devices, for which the manufacturer has submitted an application for MDR conformity assessment by 26 May 2024 at the latest, will benefit from the extended transition period.
(2) Extension of certificates’ validity, provided the conditions for the extension of the transition period are met. Also certificates that have already expired after 26 May 2021 may be considered to be valid if additional conditions are met.
(3) Transfer of appropriate surveillance to MDR notified bodies by 26 September 2024 at the latest.
(4) Introduction of a temporary derogation until 26 May 2026 from requirement for quality management system certificate for class III implantable custom-made devices, subject to conditions.
(5) Removal of the ‘sell-off’ date in MDR and IVDR, allowing devices that have been placed on the market before or during the transition periods and which are still in the supply chain to be further made available without time limitation.
If you have a legacy device that is eligible under the criteria of Article 120 (2) MDR as amended, it will have either been extended automatically or relived automatically today. Automatically, magically! Because that’s what legislation can do. No need for formal confirmation needed. Clarification probably – so read on. And maybe check the flowchart I posted earlier:
For importers and distributors it is important to realise that the amendment changes the concept of ‘legacy device’ dramatically into a device that meets new article 120 (2) and (3a) – (3e) MDR. If they have procedures in their QMS that define the concept of legacy device so they know what it is (how else could they otherwise see if the device is compliant?) they should amend these procedures immediately as the new definition has entered into force today. This definition is different from the one in MDCG 2021-25, mind you. As of today this MDCG guidance is outdated on this point, but it is not yet slated as under revision by the MDCG although it totally should be now because the core definition is outdated. That should definitely have had some priority with the MDCG, given the enormous role legacy devices will be playing in the Union for a long time now.
On the other hand, for importers and distributors of IVDs this is not relevant, as MDCG 2021-25 does not apply to the IVDR, so there is no formal IVDR legacy device concept (yet), which seems rather inconsistent since the IVDR has been applicable for almost a year.
How will I know?
How can I show to others that my certificate is actually valid? While the operation of the extension of or reliving of the duration of the certificates is automatic, that does not mean that you will automatically see this translated into a new or amended certificate. And the amendment does not provide for a mechanism for this. How you are going to prove to the rest of the world that your expired certificate is actually still valid is therefore somewhat of a mystery at this point. This should become clear in Q&A guidance that was scheduled to be published this week. But the good part is that the law is on your side, even if the guidance is slow or still lacking. There seems to be a project of the notified bodies underway for a model administrative annex to the certificate that says that the invalid certificate is nevertheless valid because the law says so. Also, you yourself should work on convincing rationale to explain to others how the certificate is nevertheless valid (or find yourself a ghost writer like me perhaps), e.g. to a competent authority that you have asked for a certificate of free sale, in case your notified body is slow, not ready with the template, or whatever.
Sounds somewhat counterintuitive if you consider what a certificate is supposed to do in the first place, but this is the consequence of the EU policy decision that directive certificates cannot be amended anymore after 26 May 2021, when the MDR became applicable and the AIMDD and MDD were repealed.
Other known unknowns
There are still other known unknown as well, such as what a substitute device is. Maybe these questions are also answered in the Q&A document that we have not seen yet. Maybe that document will even be published later today. In any event, watch this blog and my LinkedIn.
The sell-off periods in both the regulations are removed. This means that devices that are placed on the market in the Union (not the EU, but the Union – different things, as explained above) in time before the expiry of the certificate can be sold off for ever, which is actually a pretty long time (of course limited by expiry dates for sterility and such). That means that all economic operators with article 13 and 14 MDR obligations will need to be able to distinguish between MDR and legacy devices forever, as discussed above. Again, potentially a long time!
It’s a good thing that the MDCG is also revising MDCG 2021-27, in which the MDCG erroneously states that the transfer of a property right is a precondition for placing on the market, which is manifestly wrong if you look at the inconsistencies of the Blue Guide language versions and the internal inconsistencies in the Blue Guide that this interpretation creates. It would also be nice if the internally inconsistent language versions of the Blue Guide could also be amended on this point too.
It would take only a small corrigendum, how difficult is that. If the Commission could magically change the transitional regime of the MDR in 2019 with a just corrigendum, I’m pretty sure it’s not that hard to fix this error in non-binding guidance that is continuing to cause a lot of confusion in the market.
Everybody is part of the solution
I cannot stress enough that for the amendment to have the intended effect every stakeholder should be part of the solution: competent authorities, notified bodies and industry.
From what I’ve seen so far the first two groups are not chomping at the bit. This may not be a statistically relevant example but the first reaction of the Dutch Minister of Health on LinkedIn to the Council finishing the first reading was telling: manufacturers have to get a move on now to get MDR certified as soon as possible.
The Commission was a lot more diplomatic in its reaction, stating that everyone has a role to play; the Commission, the competent authorities, the notified bodies and industry are all responsible for making this work. In that sense I think the civil servants supporting the Dutch Minister really had not picked up what the amendment actually is about and this led to a stream of very angry comments to his post on LinkedIn. When the Dutch Minister was later asked by press whether the statement was intended to single out manufacturers the Minister’s spokesperson did give the right answer that all parties involved have a role to play. Still, if this is the knee-jerk reaction of competent authorities and governments in the Union, we are going to have a problem with the rollout as the competent authorities may not see themselves as part of the problem will not do their best to ensure an expedient roll-out of the 19 points of MDCG 2022-14, which itself by now dates back to September 2022. Yet, in practice do not yet see a lot happening in terms of action by competent authorities and notified bodies. I have seen notified bodies giving their customers the most technocratic of ‘computer says no’ answers when asked how the customer could best prepare for an amendment of which we knew exactly what it was going to say, and even stating to customers that it might be end 2023 before the amendment would be completely clear. Given the 26 May 2024 deadline for a regulatory filing under the MDR in the amendment this kind of behaviour is really not helpful at all.
In the mean time the Commission has delivered with two Commission delegated acts deferring the timing of the complete re-assessment of notified bodies, capacities of notified bodies and national designating authorities have been freed that can be used, in the former case, for the conduct of conformity assessment procedures and, in the latter case, for the designation of applicant conformity assessment bodies.
Manufacturers, for their part, should keep in mind that the amendment does not give them more time to get their MDR act together – it really does not. In all scenarios an MDR application must have been lodged by 26 May 2024 (even for the class III implantable custom made devices, in whose case it concerns an MDR QMS application) and manufacturers are well advised to definitely try to submit their MDR application not at the very last moment before 26 May 2024, because there will be chaos and mayhem just before that date. Just like every sane person can understand that you do not go Christmas shopping the day before Christmas for absolutely obvious reasons, the same applies to making your MDR submission May 2024: the system will be packed, log-jammed, overloaded – whatever you like to call it, and your application may not be considered timely lodged. And that would be a pity. So be a smart company and improve your chances by submitting earlier! Or join the big formalities lottery (also not clearly provided for in the amendment) to find out on 27 May 2024 about your 25 May 2024 submission being thrown out on a formality that you will not be able to fix anymore. That would not be good corporate risk management because having a valid CE mark only goes right to your core business continuity, so it is kind of important. If your management, or anyone in the company with responsibility in these matters, thinks that the year 2027 or 2028 is intended to give you as company more time and wants to act on it, consider these people a business risk to the company. The company should perhaps consider moving them to a position that is less risky to the company, like maybe mindful gardening in the company greens around the building or company barista. The only time you can buy under the amendment is the situation where your certificate is extended or relives, but you decide not to make an MDR application by 26 May 2024. In that scenario your certificate will be valid until 26 May 2024, but you would still need to meet the conditions for extension or reliving of the certificate in the first place (legacy cert not expired at date of entry into force of amendment (i.e. today), or article 59 derogation / article 97 exemption in place at date of entry into force of amendment (i.e. today).
There are still some knobs to turn to smooth out the biggest unexpected issues. It may be that the Commission and MDCG ease up a little on what will be deemed to be a formally lodged application by 26 May 2024 as required in the proposal. It may be that you are able to agree to a submission plan with the notified body that allows parts of the technical documentation to be provided later. But what that would look like needs to become clear and would (preferably) not differ from one notified body to the next.
The Commission is already one step ahead, discussing the implementation of the amendment and the future of the EU’s medical devices regime, which is still in dire straits. According to an information note of the Commission for the 14 March EPSCO Council the MDR is way not in the safe zone and the amendment and MDCG 2022-14 roll-out will need everyone’s full attention and participation. In that sense I would urge competent authorities to closely monitor how their notified bodies are doing in terms of being part of the solution in that regard. On the other hand, the authorities themselves should not be part of the problem by keeping notified bodies in the dark about what additional flexibility they are now afforded.
Important about this Commission information note are the forward looking part and some conclusions from the past. The Commission considers it important to tackle a number of structural issues before the end of the extended transition periods:
- issues related to orphan devices,
- small manufacturers’ access to notified bodies,
- length and costs of conformity assessment procedures, and
- interplay between clinical trials for medicinal products and performance evaluation studies for in vitro diagnostics.
The Commission explicitly states that these issues have appeared within the current regulatory framework and have a negative impact on patient safety, public health and medical innovation, which is a big admission about how the Commission sees the success of the MDR so far, and what is causing the flaws in the MDR that have led to the MDR performing underwhelmingly. It also shows that the Commission does not seem to believe that the current actions on some of these points will actually do the trick.
For example, I personally have absolutely no confidence in the SME measures taken via the EU4health program (developing material and activities to support market operators, in particular SMEs, in meeting the requirements of the MDR and IVDR – too little, too late and not what is needed). What is needed is that SMEs are not turned down when they present themselves at a notified body. I’ve often made comparisons with medicines marketing authorization procedure. Would we accept there if an agency says: “we have no time for you because we have more interesting applicants that already take up all our time?”. Of course not. Yet, we are perfectly happy to have this situation exist and continue in medical devices. This is why more and more SMEs go US first these days: they have a reliable and predictable pathway at a well-organized agency that is happy to help (especially if you have breakthrough designation (which we don’t have in Europe either)). Even SMEs these days have options outside of Europe if their innovations are not appreciated here. And the worst is that their innovations have often been developed with EU or local financial support and subsidies or tax facilities – yes, that is how you waste capital and innovation. Congratulations. I see this happen with clients increasingly often and it frustrates me to no end.
The Commission will gather further evidence for the comprehensive evaluation of the MDR and IVDR due by May 2027 (Article 121 MDR and Article 111 IVDR). So let’s see how things go and let’s hope no time is wasted. As they say, never waste a good crisis, and now is a good time not to waste this one even further.