The MDR amendment proposal: more than meets the eye

Open one jobOn Friday 3 April 2020 it finally happened: the Commission proposal for amendment of the MDR to defer the date of application with a year that everyone was waiting for and was in the works for some time was finally published.

As I have heard from many directions immediately after the announcement of the proposal being in the works people far and wide sighed “told you this would happen” or “inevitable”, and then dropped MDR preparatory work. The joke’s on the silly Europeans, of course they would never let it come to the DoA situation (jokingly called Dead On Arrival instead of Date of Application) that the MDR was heading for. Pfew, business as usual – now let’s concentrate on the COVID-19 pandemic.

Don’t forget however that it’s exactly this pandemic that led to this proposal. If you have been banking on the DoA being moved all along, you have been putting your company’s business on the roulette table. This proposal would not have happened if the COVID-19 epidemic had not taken place to compound access to devices related problems. Actually, this is how bad things needed to get before the EU would even consider this move.

Dropping all MDR work is still the worst choice you can make under the circumstances. This is a proposal. It’s not law yet. Although it is likely that the proposal will make it, it is also possible that it does not. While there is a lot of can-do mentality in politics these days, there is also a lot of zero sum mentality. So don’t count your blessings just yet – this may still not play out as expected.

If you are a smart company, read the ISO 31000 standard and learn a thing or two about risk management with respect to company plans regarding regulatory changes (I will blog about this at a later moment too). Scenario anyone? It would be the responsible thing to do under these circumstances.

More detailed table analysis

I have set up the analysis underlying this blog in a far more detailed table based analysis that ports every amendment to subject and MDR clause affected, consequences and my comments. My clients and good friends are very welcome to send me a request for this underlying detailed table analysis.

For everyone else, the following is a summary of this table based analysis, which does not cover every single aspect of the proposal. For example, this blog does not cover the proposed measures in the field of devices manufactured using non-viable tissues, cells or derivatives of animal or human origin.

When making this analysis I found that there is a lot that does not meet the eye immediately with this proposal, and I may have missed things as well. The proposal really affects a lot of different things, and does much more than just move the DoA with one year.

Objectives of the proposal

The proposal has three broad objectives:

  1. deferring application for provisions of Regulation (EU) 2017/745 that would otherwise start to apply from 26 May 2020 (see recital 6);
  2. it is also necessary to adapt certain transitional provisions of Regulation (EU) 2017/745 that would otherwise no longer apply as from the date of application of those provisions (see also recital 6); and
  3. giving the Commission the possibility to apply article 59 MDR before the DoA so it can start taking Union wide central measures as soon as possible to address all kinds of problems both COVID-19 and MDR bottleneck related.

See for details on all three objectives in the following, where you will also see that there are some Easter eggs in there, for example as regards EUDAMED.

The proposal ONLY covers the MDR, not the IVDR. Did I say already that the IVDs are on their own right now and that this is another crisis in the making? Yes I did. But I also provided a solution for the IVDR, which could be implemented by means of a similar amendment as to article 59 MDR and associated provisions in this proposal to the article 54 and associated provisions in the IVDR. Not addressing the IVDR bottleneck in this proposal is – in my opinion – a terrible mistake that will cost us lives. Shortage of COVID-19 tests everywhere, so let’s not fix the devices shortages for the IVDR. Makes perfect sense, right?

Annex XVI devices – more time for CS

For the Annex XVI devices all 26 May 2020 dates move to 26 May 2021. This means that Common Specifications for Annex XVI devices can still be adopted ‘in time’ before the new DoA of 21 May 2021, or six month after the date that they are adopted on after DoA.

Reprocessing of SUDs – more time for CS

Similarly, the date for adoption of CS for reprocessing of SUDs will be moved to 26 May 2021. More time to adopt those too.

If the CS have not been adopted by the new DoA, alternative standards apply (relevant harmonised standards and national provisions).

EUDAMED – Big Bang launch back on the table?

Everyone’s favorite super complex moving target! What happens with EUDAMED is one of the really interesting things in the proposal. Because of the way the dates concerning Eudamed are moved, a Big Bang launch of EUDAMED on the (new) date of application as originally intended in the MDR is suddenly back on the table. With the dates moved the whole original itinerary of EUDAMED phase-in is possible again, including a ‘EUDAMED is ready’-notice on 25 March 2021. Now that would be news, wouldn’t it?

This means that if the proposal is adopted and the MDR amended accordingly there is a perfectly legal alternative to the Commission’s December 2019 move of the date of EUDAMED going live to coincide with the IVDR DoA. The proposal and other public materials (like the Commission press release about the proposal) are completely silent on this point. So this is one to watch: EUDAMED for MDR goes live on 26 May 2021 (new DoA) or on 26 May 2022 (as deferred by the Commission)! And what will happen in the mean time with the phased making available of voluntary use of modules, starting with the actor module? What will it be? Scenario anyone?

EU wide conformity assessment derogations – NEW

This is another real change brought about by the proposal. As the explanatory text to the proposal mentions, when adopted the article 59 MDR procedure that allows national measures exempting groups of devices from the normal conformity assessment requirements will also apply ahead of DoA. As a result the Commission will have a shiny new pan-Union instrument that is badly needed in the COVID-19 times, which is one of the proposal’s core objective.

The Commission would be allowed to roll out a national measure for the whole Union (not just the EU, but the Union in which the MDR applies, which is relevant for the Brexit, Swixit and Turkxit – more about that below) by means of implementing act.

This new instrument will allow the Commission to implement the policy of which the outlines were set out in the Recommendation of 16 March 2020.

Sanctions – more time for Member States

The date at which the Member States should have informed the Commission about the sanctions they impose on MDR infringement will be moved to 25 February 2021, giving Member States more time to finish their implementing legislation for the MDR.

Since many Member States have not finished their implementing legislation, this is a welcome delay.

Notified bodies – More time for MDR certificates pre-DoA and (AI)MDD renewals, but less time for MDR certificates pre 2024

The move of DoA and related dates with one year to 26 May 2021 gives the Commission and the Member States one more year to designate notified bodies for the MDR, and it gives the notified bodies already designated for the MDR more time to issue more MDR certificates, as well as renew more AIMDD and MDD certificates that were still in the pipeline for renewal to profit from the article 120 (3) soft transition period. 

On the other hand, there is less time for notified bodies to convert AIMDD and MDD certificates to MDR certificates during the soft transition period, which can create other problems because the market went all in on extension of old certificates rather than the issue of MDR certificates pre-DoA, because there was not enough capacity for pre-DoA certificates. This will mess with everyone’s 2020-2024 planning, including yours. For a very detailed overview of how everyone’s planning will be affected from the perspective of a notified body, I refer you to Bassil Akra’s (TÜV SÜD) analysis. This analysis also contains a lot of good tips for interaction with your notified body and what notified bodies will be doing in case the proposal is adopted. Maybe read ISO 31000 and make a scenario or two.

Article 120 (3) MDR ???

The proposal does not move the date of 26 May 2020 mentioned twice in article 120 (3) MDR, which creates some urgent problems.

First, the consequence of not changing this date is that it partially undermines the second Corrigendum, which was intended to allow up-classified class I devices and the new category of reusable surgical instruments in class I the same benefit of article 120 (3) MDR as was granted to devices with a CE certificate under the AIMDD and the MDD. The consequence of the proposal being adopted as is would be that there is a year (between 26 May 2020 and 26 May 2021) during which the MDR does not apply, but up-classified class I devices and reusable surgical instruments are already subject to soft transition requirements (no significant chances and MDR QMS elements) before the (new) DoA, which was not how the Corrigendum 2 intended things to work and which is not how the article 120 (3) exemption system was set up. However, this is where we will  be if the proposal is adopted as is.

My theory is that someone did not have his or her consolidated version of the MDR at hand, because the pre-Corrigendum 2 MDR text for article 120 (3) does not contain that date, and therefore would not need amending based solely on that text. Sometimes legal issues are as simple as that, but they can create massive problems. If you do a full text search through the MDR, the only “26 May 2020” date that was in the pre-Corrigendum 2 MDR text that did not get addressed in the proposal is the Annex I 10.4.3 provided 26 May 2020 final date for the SCHEER mandate to prepare guidelines on phthalates. This date did not need to be moved because the guidelines have been prepared already – they were adopted on 18 June 2019 so there was no need to move this date. Really, the explanation may be that banale but I’m open to other theories because those would be a much better story than administrative oversight.

Secondly, the soft transition period for devices with a CE certificate before 26 May 2020 is impacted, which would have run from 26 May 2020 to 26 May 2024, so the logical thing to happen would have been to change the second date of 26 May 2020 in article 120 (3) MDR to 26 May 2021, which did not happen, thus shortening the soft transition period from four years max to three years max, like happened with the sell-off period in article 120 (4) MDR, discussed below. Like with the up-classified class I devices, this creates a year during which the MDR does not yet apply, but the article 120 (3) MDR regime does and similarly it does not make sense here either.

However, also this apparent oversight can be explained by the fact that the second date of 20 May 2020 just did not feature in the pre-Corrigendum 2 MDR text and someone apparently did not look at the consolidated text when drafting the proposal (see above explanation). It also does not make sense to not change the date in article 120 (3) for existing AIMDD and MDD certificates because article 120 (1) MDR is changed in the proposal (article 1 (6) (a) of the proposal) to keep the notified bodies that otherwise would be de-notified by 26 May 2020 notified for another year so they can continue as usual. Recital 6 of the proposal states that:

“The application should be deferred for provisions of Regulation (EU) 2017/745 that would otherwise start to apply from 26 May 2020.”

That would mean all provisions (since no reservation was made, e.g. by using ‘certain provisions’) starting to apply on 26 May 2020 are intended to be deferred, including those in article 120 (3) MDR. In my view this further supports the theory that this is an unfortunate oversight. The Commission intends to keep the notified bodies supporting existing MDD and AIMDD certificates notified for another year (which they would not be during the article 120 (3) period), which makes no sense logically if the article 120 (3) period would not be shortened accordingly.

If these two issues with article 120 (3) MDR are really not intended, this is obviously sloppy work on the part of the Commission. They had one job, and and it would be very sloppy if they had used an obsolete legal text for that.

If these issues are intended, the logic behind them escapes me completely because they serve no other purpose than to complicate things enormously and are a recipe for confusion everywhere. Again, any theory better than mine is welcome!

Sell-off period – shortened

While The DoA is moved to 26 May 2021 with a change of article 120 (4) MDR the end date of the sell-off period does not change (27 May 2025). This means that economic operators will have less time to sell off devices that have entered in the supply chain before the date of application.

Date of Application – moved

Obviously the date of application will be changed – this was the whole point of the proposal. But mind you, since so many things are connected (remember, CE means Connected Everything under the MDR), a lot of other things start to move as well. I have mapped all of these in the detailed table for clients and friends referred to above.

UDI carrier – much ado about nothing

A lot changes in the text relating to UDI carrier timing, but the net result is zero.

Because of the move of the DoA, the date on which class III and implantable devices have to start applying UDI carriers on label and packaging is now on DoA and not one year after anymore. The textual changes are necessary to make this work.

Entry into force of proposal and procedure – let’s hope it all works

Several measures have been taken to fast-track this proposal as much as possible. Article 2 of the proposal provides that it enters into force upon publication in the Official Journal, while this would normally be 20 days after publication. Together with the eight weeks saved by foregoing the national parliaments procedure (see recital 12 of the proposal) the proposal can be accelerated by almost 11 weeks. The amended voting procedures for Parliament and Council that do not require voting by personal presence can lead to further acceleration, as well as some other tweaks in procedural formalities that would be out of the question under normal circumstances.

For the rest, the Commission is betting on nobody being difficult basically, as the Commission says understatedly in the press release:

“The proposal would need the full support of the European Parliament and the Council through an accelerated co-decision procedure.” 

So let’s hope nobody is difficult. Because if they are, this proposal may well not make it in time to make a difference and then it will likely be off the table altogether. For example, if the issues discussed in relation to article 120 (3) MDR are indeed not intentional, we will need amendments. The reality of amendment is that they time, because there are procedures to be followed so everybody can say what they think about them. And the Commission must be in a position to still make amendments. Let’s hope that the Commission finds a way in this case, because otherwise we need to sit through the first reading first before amendments can be made. This might jeopardize timely adoption of the proposal.

Brexit, Swixit, Turkxit

For the influence of the proposal on all these contingencies (scenario anyone? ISO 31000 says it’s the responsible thing to do) see my previous blog about this proposal’s announcement. The proposal, if adopted, would mean another year before the Swixit and Turkxit take effect, and effectively therefore another year to sort things out politically. That may or may not happen.

In addition I can say that the UK’s play to synch timing and substance of their own new devices legislation with that of the Union turns out not that well if the MDR does get moved. If there is a hard Brexit a the end of 2020 – which is the likely scenario in my view given how things are going – the UK will find itself in the truly weird place of having stricter and more complex devices rules than the Union. This is of course totally not what they intended, even if this situation will last only for a limited period of time. Welcome to the reality of being on the outside, UK.

Overall impression – will it blend?

I really hope that the proposal will pass the co-decision procedure swiftly.

In my view the proposal marks a welcome (in my view anyway, as I’m a passionate European) transfer of competence to the EU level. Subsidiarity is a very nice principle, but it really needs to be rethought in view of healthcare policy, as it made painfully obvious by the current situation.

If there is one thing that we can learn it is that market access for medical technology needs more central handling, because healthcare is too precious. We have the best healthcare systems in the world in the EU, and it would be a terrible mistake to cripple them by not arranging for more effective centralized market access for devices to make them function as intended. We would fail our citizens knowingly and deliberately. It’s only logical if we really want

“a robust, transparent, predictable and sustainable regulatory framework for medical devices, which guarantees a high level of protection of public health and patient safety and the smooth functioning of the internal market for such devices”

as set out in the proposal.

Other than a step in the right direction with article 59 MDR, there are some very critical observations that should be remedied in opinion.

Of course not arranging for the bottleneck in the IVDR to at least allow COVID-19 tests related national measures to go through the article 54 IVDR procedure in order to be able roll out central measures relating to tests I think is a missed opportunity that is going to cost us dearly in lives. Apparently that’s what it takes these days before we do something completely rational. What crazy times we live in.

Then there are the things that do not seem to have turned out right in the proposal, notably the not moving of the DoA in article 120 (3) MDR. If this was not intended, an amendment must be made and amendments normally take time because there should be opportunity to discuss them. This could jeopardize timely adoption of the proposal. Let’s hope nobody is difficult about any amendments either.

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