Verelendung is a process, people!
Over the summer holidays I (and perhaps some other people too) were in burning anticipation about announced measures to be adopted to deal with the MDR slowly moving to a big crunch or other equivalent astrophysical end state event at the end of the grace period.
MDCG 2022-14 on Notified body capacity and availability of medical devices and IVDs has finally dropped now, but it’s pretty underwhelming and contains a lot of wishful thinking. In fact, it makes you wonder if there even is any sense of urgency at all about this MDR and IVDR business in Brussels and in the member states that make up the MDCG.
For example, I have seen the first manufacturers of non-medical devices enter the regulatory limbo where their MDD certificate has expired while they cannot even apply for MDR Annex XVI device conformity assessment. Why? The Common Specifications that we have been waiting for for years and years are still not final since member states do not seem to be able to agree on them. There is currently a proposal in consultation for classification of these devices (no conformity assessment without classification), which we will also have to wait for to complete, because no conformity assessment without classification. These manufacturers can be as prepared as possible but there simply is no regulatory pathway available to them at this time, which is something too surreal to credibly explain to my clients. Just wait and see your European market collapse, because the good people in Brussels are unable to issue Common Specifications in five years. Why? How? Is this how the EU shows to the world that it has a reliable regulatory system for devices?
And I can give other examples of permutations where more and more manufacturers are starting to fall through the cracks of the system that have been visible for a long time but were never properly addressed. Why? How? Is this how Europe shows to the world that it has a reliable regulatory system for devices? How are these manufacturers supposed ‘to ensure timely compliance with the requirements’ if the system does not have any options?
Your guess is as good as mine.
Calls on to please cooperate
The document contains 19 points with a lot of ‘should’ or ‘calls on’, but no ‘shall’ (which is somewhat logical because it’s an MDCG document, and not law) and – frustratingly – puts many items that could make a difference but are on the ‘we will get to this at some point’ path (e.g. Eudamed machine-to-machine communication for notified bodies and revision of certain MDCG guidance), while we need them now, or rather would have needed in 2017 already. It just underlines what I’ve said before: that the MDR and IVDR entered into force prematurely and that subsequently insufficient resources were committed to the system fix this quickly. Enumerating 19 points where things need to improve and call upon on others to fix it is nice but wishful thinking is not the same as decisive action.
There are also things in there that the MDCG would like but has 100% influence over itself, such as that medicines authorities would please ‘accept and efficiently process consultations by notified bodies regarding medical devices incorporating an ancillary medicinal substance and regarding companion diagnostics’ (point 19). Yes, that would be nice indeed if that actually happened. But the MDCG is populated by member states, and medicines agencies are member state agencies. So the member states can just order their agencies to process these applications, it’s just a matter of doing it. If there is no capacity at the medicines agencies, fix this. Member states calling on other parts of themselves to play their essential role in a regulatory systems like they have no influence over this is indeed as absurd as it sounds. All that is needed is high up enough political will to make the overall regulatory system function, rather than to allow compartmentalized parts of it to miscommunicate or not align with each other.
Some small items that might make a difference
However, there are some items in there that might make a difference if these are actually done (‘should’, remember?) by all member states and all notified bodies.
The document suggests that hybrid audits would be allowed and encourages them. This is no news actually, but the Commission already stated a long time ago that member states are at liberty to allow their notified bodies to do this, except that certain member states just chose not to do so. Will this document end that? Not necessarily. Member states that do not want to play along are completely not bound by this document.
One of the notable points is allowing notified bodies to have ‘structured dialogues’ with manufacturers before and during conformity assessment that would not count as prohibited consultancy and a more pragmatic approach to MDR assessment of legacy devices. This would actually a be a big help in practice, and notified bodies as well as industry have been asking for this for a long time. Unfortunately the line between structured dialogue and consultancy has not been defined, so member states can still think about this completely differently and instruct their notified bodies differently.
Also there is an interesting initiative to make adding codes to notified body designations easier, which could make a huge difference for example with respect to notified bodies having to also qualify as notified body under the draft AI Regulation for medical devices that incorporate AI.
Many of the other points call for pragmatism and flexibility in conformity assessment, which sounds kind of hollow given the formalistic approach that the MDCG itself has taken to MDR and IVDR implementation so far and given the restrictions preventing anything pragmatic that have been so far imposed on notified bodies by their notifying member states, landing things in the place where we are at the moment. Will all of that change now? Seeing is believing.
No love for SMEs
If you are an SME that is getting no love from a notified body for your first application, your problems are way not solved. The MDCG calls upon notified bodies to develop schemes to allocate capacity for SMEs, but it does not get more concrete than that. There is a vague what, but certainly no how, which would have been helpful. This means that every notified body is on its own on this point, and may be second guessed by its notifying authority.
The MDR and IVDR are really failing the SMEs here, while the majority of medical devices manufacturers actually are SMEs. The EU already managed to kill the EU market of SMEs in ATMPs with an overly complex and expensive regulatory system in the ATMP Regulation that made it prohibitively complex and expensive for SMEs to obtain a marketing authorisation for an ATMP. Next up seem to be medical devices and IVDs now.
Legislative measures in the works?
Finally, legislative measures are in the works but not what many may be hoping – only Commission Delegated Acts to modify the frequency of complete re-assessments of notified bodies, based on Article 44(11) MDR and Article 40(11) IVDR. This would help to reduce the burden on notified bodies and may free up time of otherwise tied up staff for MDR and/or IVDR work. In that sense this is a good development. But it will not make a decisive difference.
So no article 97 (3) MDR implementing act (yet!) or anything else (so no moving of deadlines either, for the hardcore wishful thinkers out there). An article 97 (3) MDR implementing act might still be on the table according to the document, since it apparently is in the realm of ‘being explored’ and ‘where relevant, work towards a coordinated, transparent and coherent approach’. But such ‘mechanisms provided in Chapter VII of the Regulations, such as market surveillance measures, may only be applicable for devices for which manufacturers can demonstrate that they have undertaken all reasonable efforts to transition to the Regulations’. See my previous blog on this point.
More in detail: a table
To make it a bit more systematic, I’ve put my comments in a table and grouped the 19 items in the position paper in groups. As you will see, in many cases things completely depend on the MDCG following its own wishlist in the position paper. I think it’s not a good sign how much is put on the plate of the notified bodies without further detail or structure, so the MDCG can hide behind its ‘somebody else’s problem field’ and say that it did all it could and the rest is not its problem. The MDCG also ‘calls’ upon member states and seems to conveniently forget that the MDCG is composed of the member states.
|MDCG position paper||Comments|
|Increase notified bodies’ capacities|
|1. MDCG advises notified bodies to make use of hybrid audits||It is kind of tragic that could have been possible all along, if only the member states would have let notified bodies do this and would have used a unified approach. And the MDCG did already allow this for certain types of audits in the past.|
|2. MDCG encourages notified bodies to develop a framework for leveraging evidence, or components thereof, from previous assessments conducted with regard to requirements under the Directives.||This could be useful, were it not that the MDR and IVDR are very different on many points compared to the directives (e.g. in the field of clinical evidence), which is kind of the point of the new regulations. Notified bodies will need more structure than this as a foundation for a ‘framework’ that will be acceptable to the member states.|
|3. With regard to ‘appropriate surveillance’ of legacy devices, the MDCG calls on notified bodies to make full use of the flexibility described already in MDCG 2022-4 on ‘appropriate surveillance’ under Article 120(3) MDR.||The problem is that MDCG 2022-4 does not give that much flexibility, because “the notified body’s activities in principle should be a continuation of the previous surveillance activities under the Directives” so full use of very little flexibility that is imprecisely defined is still not very much.|
|4. MDCG will review its guidance with a view to eliminate administrative workload of notified bodies or undue limitations regarding the scope of documentation not required by MDR/IVDR.||This review is of course welcome but very very very late in the day. Moreover, notified bodies would benefit from a single approach by the notifying member states, which up to now has not materialised.|
|5. MDCG considers that in the framework of the development of Eudamed it should be ensured as soon as possible that notified bodies can upload relevant information machine-to-machine. Moreover, generally the MDCG acknowledges that double registrations should be avoided to the extent possible.||Yeah, wouldn’t it be nice if Eudamed would be functional at some point ever.|
Double registrations can be avoided by just not asking for them as member states and by just not setting up parallel information systems. This is completely under control of the MDCG members themselves.
|6. MDCG calls upon all parties involved to foster capacity-building of existing and potential new notified bodies and to rationalise and streamline internal administrative procedures, and ensure that proper conformity assessments are carried out in a timely and efficient manner in accordance with the Regulations.||There is scarcity of qualified personnel in the market and procedures will have been streamlined by now.|
|7. MDCG welcomes the preparation of Commission Delegated Acts to modify the frequency of complete re-assessments of notified bodies, based on Article 44(11) MDR and Article 40(11) IVDR.||When will this be ready? A consultation draft has not been published yet.|
|8. MDCG calls upon all parties involved in the assessment, designation and notification of conformity assessment bodies to continue to make all efforts to speed up this process, while preserving the level of requirements to be met by notified bodies under the Regulations||It would be nice if the MDCG and the Commission took this to heart themselves too, because the longest hold up in the process concerns the step where the Joint Assessment Team (JAT) evaluates the NB’s proposed CAPA plan.|
|9. The MDCG will explore means to add codes to the designation of notified bodies in a timely manner in accordance with the Regulations.||‘explore to do something in a timely manner’ – sounds like high priority indeed.|
These codes could be very useful, because it could help for example to avoid having to notify NBs under the (draft) AI Regulation that are already notified for AI under the MDR and IVDR.
|10. The MDCG commits to prioritise actions that are ongoing in the MDCG or its sub-groups, which aim at contributing to enhancing notified body capacity, such as the revision of section III.6 of MDCG 2019-6 revision 3 regarding the meaning of ‘personnel employed by the notified body’ referred to in Article 36(1) MDR / Article 32(1) IVDR.||The MDCG has been prioritizing actions for years now in its permanently moving planning, and we know what this looks like. I’d like to know how things would change in a way that this leads to things being actually expedited.|
|11. As regards the status of MDCG guidance documents, MDCG reminds that their main objective is to assist economic operators, notified bodies and competent authorities to apply the legal requirements in a harmonised way, providing possible solutions endorsed by the MDCG. Having regard to the status of guidance documents, economic operators and notified bodies should be allowed flexibility as to how to demonstrate compliance with legal requirements. Moreover, reasonable time needs to be given to integrate new guidance in the relevant systems and/or to apply them. That means that new guidance should not be applied to ongoing processes or applications already launched by a conformity assessment body for designation and/or a manufacturer for conformity assessment, unless application of such guidance yields increased efficiency of the process.||Told you so, guidance is not binding. No retro-active pplication of guidance unless it increases efficiency of the process. For whom? What does that mean? Either it’s binding or not and the MDCG is still sitting on the plausible deniability fence here. “reasonable times to integrate” and “not, unless” are meaningless principles from a legal certainty perspective.|
|Access to notified bodies|
|12. The MDCG reminds notified bodies of their obligation to make their standard fees publicly available (Article 50 MDR / Article 46 IVDR), taking into account the interests of SMEs in relation to fees (section 1.2.8 of Annex VII MDR / IVDR). The MDCG also encourages notified bodies that fees published are easy to compare.||This will have zero effect on access to notified bodies, as all available notified bodies are already full. As a result of scarcity fees are as high as they will get under these circumstances. If the MDCG wants to do something for SMEs it will have to be more precise.|
Asking for fee structures that are easy to compare is like encouraging mobile telecoms companies to use easy to compare fees: not going to happen until it is prescribed in detail how and this is mandatory.
|13. The MDCG calls on notified bodies to develop schemes in order to allocate capacity for SME manufacturers and first-time applicants and ensure access of SMEs and first-time applicants to notified bodies for conformity assessment.||See comment under 12. Also, like under 12, nice move to pass this on to notified bodies, who are not allowed to discriminate between customers. Some insights in what a scheme should look like would have been helpful.|
|Increase preparedness of manufacturers|
|14. The MDCG reminds manufacturers of its notice MDCG 2022-11 calling on manufacturers to ensure timely compliance with MDR requirements. The MDCG also calls on manufacturers to ensure timely compliance with IVDR requirements as soon as possible, making use of available notified body capacities, and not wait until the end of the transition periods. The MDCG is committed to supporting the transition to the Regulations and avoid shortage of devices.||Yes, this is super helpful for the non-medical devices manufacturers and the others that are delayed at notified bodies or find themselves unable to find a notified body. There is no degree of preparation that will fix that.|
|15. The MDCG encourages notified bodies and manufacturers to organise structured dialogues before and during the conformity assessment process aimed at regulatory procedures where this is useful to enhance the efficiency and predictability of the conformity assessment process, while respecting the independence and impartiality of the notified body. Such dialogues should not be considered consultancy service.||Too little and unclear, and too late. This could have made a lot of difference some time ago when the first notified bodies were nearing the end of the designation procedure.|
Also, without internal agreement in the MDCG each member state will hold the notified bodies it notifies to different standards as has happened so far, unless this has changed (which I don’t expect because the MDCG does not encourage the member states to take a unified approach here). Finally, it remains quite unclear how a ‘structured dialogue’ before or during conformity assessment can be reliably (legal certainty anyone) be distinguished from consultancy, which still remains prohibited.
|16. In order to increase preparedness of manufacturers, especially SMEs and first-time applicants, to adapt to the high-level standards set up by the Regulations, the MDCG calls on all parties involved to continue and, where possible, to step up communication with manufacturers by means of webinars, workshops, targeted feedback and informative sessions. […] Also industry associations are invited to promote and ensure awareness of economic operators of the legal requirements.||Seriously, industry associations should step it up? MedTech Europe, COCIR and their national organizations have been more than vocal for years in communicating about this. Conversely, not every MDCG member state did a lot in their jurisdiction in that regard, that’s for sure.|
|Other actions facilitating transition to MDR/IVDR and/or avoiding shortage of devices|
|17. Provision of additional guidance to notified bodies and manufacturers to assist with the practical application of Article 61 MDR (clinical evaluation), and possibly Article 56 IVDR (performance evaluation and clinical evidence), and to make appropriate use of MDCG guidance on clinical evidence for legacy devices and clinical evaluation – equivalence. In combination with the possibility for notified bodies to issue certificates under conditions or combined with the requirement to carry out PMCF / PMPF studies, this action will increase the necessary flexibility to apply the reinforced clinical evidence requirements to devices that have a demonstrable track record of safety.||Such guidance would need to be very clear and specific, otherwise it is going to create more additional questions than answers. And member states should have internally aligned policy as to how they instruct their notified bodies on this point.|
|18. The MDCG acknowledges the specific situation of ‘orphan devices’ and will pursue work with a view to providing a definition for ‘orphan devices’ and suggesting specific guidance or other means of assistance for those products to be able to meet the legal requirements. Sustainable solutions are also needed in the mid- and long-term for orphan devices.||Better late than never, for sure. ‘Will purse work with a view to’: we’ve been hearing this about MDCG documentation that we’ve waited for for years, so seeing is believing.|
|19. The MDCG urges medicines authorities to accept and efficiently process consultations by notified bodies regarding medical devices incorporating an ancillary medicinal substance and regarding companion diagnostics. Medicines authorities should ensure that in case of devices already certified following a medicines authority’s consultation under MDD/AIMDD, an expedited review is carried out following the recommendation in MDCG 2020-1217. Medicines authorities are invited to support notified bodies in identifying availability of medicines authorities for determined devices. The MDCG calls upon the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) to take action ensuring that the consultation of medicines authorities is carried out in a cost-efficient and timely manner, in particular as regards devices that had undergone the consultation under MDD/AIMDD.||This is something member states completely control themselves, such as remedying the capacity problems at medicines agencies that prevent them from processessing these additional dossiers or even to actively implement something of a solution locally.|
The MDCG helpfully recalls that derogations (article 59 MDR and 54 IVDR) from applicable conformity assessments procedures may be granted by competent authorities only if the use of the device concerned is in the interest of public health, patient safety or patient health. Still, many companies ask me for options for a derogation. These options are basically not there, unless a device actually qualifies under article 59 MDR / 54 IVDR requirements. National derogations are hard to get (and there are differing national criteria) and a European one is even more difficult. These are not intended for manufacturers missing deadlines, these are intended for patients missing out on essential treatment.
Does this MDCG document help?
This is one of these questions that is cynically answered with: “Depends on who you ask.”
The problem is that the document is not mandatory, is not very concrete nor does it provide for actual mandatory harmonization, which means that for whatever nice things are in there the usual CE (Confusion Everywhere) problem is that where there is room for interpretation, everyone will do things differently and at their own speed.
An interesting twist is the Commission and at least one member state (The Netherlands) present the MDCG 2022-14 position paper now as an action plan; see here for Commission press release. While I am not a native English speaker, to me a position paper is not automatically an action plan. Both the Commissioner for Health and the Dutch Minister of Health mention specifically that the document contains concrete actions which, if you look at the above, is a very ambitious interpretation of what the MDCG position paper actually does. The Dutch Minister adds that there is no simple solution due to the international character of the problems and that it can be expected that these problems will not be (completely) solved in the short term. I don’t agree: the solutions are actually often very simple and very well known (for years in some cases – and see my comments in the table above, and have been pointed out to the MDCG often), it’s reaching political agreement on them in the MDCG and then attributing the system with the resources to implement them that cause the issues. All member states need to do is decide that the problem is urgent enough to merit serious attention and then act on it, and at least make sure that they support the notified bodies in this properly. It’s not more complicated than that.
But the big problem is that this is by no means certain. Member states that do not want to play along can still order notified bodies to do things differently. This will not be visible to the outside world, who will mistakenly blame the notified bodies or the Commission for the crisis and confusion. More and more than already at this moment desperate manufacturers start asking me if they can sue their notified body just to make things move again (usually not recommended in this scenario). The big issue with this position paper is that it basically calls upon notified bodies in very general terms to come up with very specific solutions to solve certain problems without there being any detailed guidance on what these specific solutions should look like. If you know the epic Gary Larsson Far Side episode “damned if you do, damned if you don’t” you know what this looks like.
I’m afraid that this position paper will result in notified bodies and member states unnecessarily looking at each other while perhaps some best practices acceptable to member states may or may not emerge, while these may be frustrated by individual member states after the fact. Sounds very efficient, right? Before you complain about your notified body not listening to what the MDCG says, it’s good to realize in what a difficult position notified bodies are with this position paper. They may be damned if they do (adopt solutions that the notifying member state doesn’t like after all) and damned if they don’t (adopt solutions that the MDCG document hints at in very general words, because their customers and the public opinion will hate them for it). Obviously, I don’t think this is a good way to solve the problem. It’s a good way to pass the buck to the notified bodies and the industry (together “the market”) and then blame the market for not fixing its own problems, for sure. But as my late grandmother would have said: passing the buck is not an actual solution.
The next EPSCO council meeting is planned in December. What will the EU regulatory system have to show by then for solutions to the problems of which everyone agrees that they are urgent? We’ll need to see. By then the MDR system will likely have painted itself into a corner again because any MDR application that is not in the door at a notified body early 2023 does not have a reasonable chance of being finished before the very end of the grace period on 26 May 2024 (because the capacity is simply not there) or to qualify for a solution that was announced in MDCG 2022-11 (application at least one year before end of grace period). And then I’m not even talking about the MDD certificates that expire (sometimes way) before 26 May, which do not even seem to be on the authorities’ radar publicly.
As Marx might have said: Verelendung [immiseration for the non-German speakers] is a process, people! Things apparently need to get a lot worse before they can get better because we are still not deep enough into the danger zone yet in the eyes of the MDCG. Let’s hope it does not get to the point where the Commission, presiding the MDCG, has to record the words that many of us have heard somewhere before: “Gentlemen, it has been a privilege playing with you tonight.”