New MDCG guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions

Schermafbeelding 2020-04-08 om 20.32.53When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation.

It addresses alternative solutions to carrying out on-site audits by notified bodies under the medical devices directives and under circumstances the MDR and IVDR under specific circumstances, which includes the possibility to perform remote audits under certain conditions.

Covered audits

Although

“this guidance applies to the medical device Directives only, for Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) in the event that the availability of devices is affected by COVID-19 restrictions the principles in this guidance may apply.”

The guidance covers the following audits:

  • surveillance audits under the medical devices Directives,
  • audits conducted for re-certification purposes under the medical devices
    Directives,
  • in cases where a manufacturer submits a change notification to a notified body that would typically require on-site audit or verification,
  • in cases where a manufacturer terminates (voluntarily or involuntarily) its contract with a notified body and enters into a contract with another notified body in respect of the conformity assessment of the same device(s).

IVDR is covered ‘in principle’! This is the first time I see something positive in guidance in relation to the IVDR. IVD companies, make this count and use this time to not give up on or start conformity assessment with the few notified bodies there are for the IVDR before these are completely crowded. This will also help fast track clearance for self-tests for COVID-19 under the IVDD and IVDR covered COIVD-19 tests. Hurrah!

Not covered audits

Generally initial certification audits or audits to extend the scope of certification under the Directives should not be performed using these temporary extraordinary measures. However, notified bodies may apply these extraordinary measures on a case-by-case basis for such audits in cases where devices are considered relevant to ensure medical care, especially if clinically necessary during the period of COVID-19 restrictions.

How?

Within the confines of audits covered and not covered the notified bodies have wide discretion on how to work, provided that the measures are covered by appropriate procedures. The guidance gives a number of examples of temporary alternative extraordinary measures and arrangements to on-site audits. The procedures should be carefully assessed and documented by notified bodies on a case-by-case basis and performed using a risk-based approach. This risk-based approach should be based on a review of the notified body’s

“files relating to the status and operations of the manufacturer related to the audit in question, for example the activities conducted at the site to be audited, its quality management system, and its level of compliance from previous audits. Following this review, a risk analysis should be made as to whether or not the audit could be performed with alternative measures. Where a postponement cannot be justified, the notified body should assess which alternative extraordinary measure should be performed (e.g. remote audit; off-site document review; conference calls with relevant personnel of the manufacturer).”

More detail coming

The guidances mentions that the MDCG NBO working group is tasked with the development of guidance to define the operational implementation details of this guidance document. More detail will no doubt follow.

MDR amendment proposal article 120 (3) oversight set to be fixed by Council

Kermit mysteryIt’s always a risk to put out a theory about legislative oversight after a Sherlock Homes investigation that eliminates all other options as I did in my last blog about the MDR amendment proposal.

Recent development seem to confirm that I was right in assuming that not touching the two dates of application of 26 May 2020 in article 120 (3) of the MDR were indeed an oversight after all.

The Council’s fix

The Council has now moved swiftly and put in a proposal to fix this. Informal discussions were concluded at the Presidency and the proposal was discussed with particular attention to the oversight with regard to article 120 (3) MDR. Based on these consultations, the Presidency believes now that a large majority of delegations can support the Council’s fix.

The fix contains an amendment to article 1 (6) of the proposal by adding a new Article 1 (6) (aa) that moves the date of application in article 120 (3) MDR to 26 May 2021 as well:

Article 1 6) (aa)Article 120 is amended as follows:

paragraph 3 is replaced by the following:

“By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2021 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.,”

Still only a proposed amendment to a proposal, but at least the proposal as a whole is consistent now.

What’s next

Stay tuned for further developments! The Council document referenced sets out the further steps to the legislative procedure:

  1. The Permanent Representatives Committee is invited to agree on a mandate based on the Presidency text set out in Annex I at its meeting on 8 April. The mandate will then be transmitted to the European Parliament in a letter in which the Chair of the Committee informs the Parliament about the Council intention to reach an agreement at first reading.
  2. The European Parliament is expected to vote its position at first reading already at its plenary on 16 April.
  3. After the vote in the European Parliament, the Permanent Representatives Committee will be invited to examine the Parliament’s position and agree if it corresponds to the Council mandate. Should that be the case, a written procedure will be used to invite the Council:
    – to approve the Parliament’s position, and
    – to agree to derogate from the eight-week period foreseen for scrutiny by the national parliaments.
  4. Consultation of the European Economic and Social Committee and the Committee of the Regions is compulsory, as this proposal concerns public health. Both consultations must be finished before the Regulation amending Regulation (EU) 2017/745 is adopted. The Council mentions that both Committees have been contacted with the aim of speeding up the consultation.

And then the proposal is hopefully published in time. Because it can enter into force on the day of publication, hopefully that will be in time before 26 May 2020.

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.

Commission working on proposal to postpone MDR date of application for one year

After a statement on a press conference today by Stefan De keersmaecker that had many people very excited quickly, the official announcement came later in the afternoon:

Schermafbeelding 2020-03-25 om 19.09.52

Here is what I think about this development.

Work on a proposal ongoing

The Commission announced that ‘work on a proposal to postpone the date of application’. This tells us something but not a lot.

A decision was reached. That sounds like the work has just started, but it is not excluded that the political foundation for the process was some time in the making.

I know that I have often said on this blog and in public that the date of application would not be moved and companies should not expect it. Now it looks like it’s happening anyway. Why is it happening now when I thought it would not happen before? It’s the corona virus pandemic that provided enough pressure for things to be fluid.

As I’ve been saying all along: the only way to the change the MDR is by means of the legislative procedure, which takes a long time under normal (normal) circumstances and requires all institutional actors to agree to stick to the proposal only and not propose any amendments that prolong the procedure.

We may have the ducks sufficiently in a row for this to succeed now but this is by no means certain, which is exactly why the Commission also uses careful and cautious wording and is by no means saying that this is a done deal.

Postpone application date for one year

What will postponement of the date of application mean? Will it mean that every date in the MDR after 26 May 2020 will also move up one year? We don’t know. I think it is unlikely to happen that every date will move, which essentially means that the four years (May 2020 – May 2024) that were originally intended to ensure

IVDR? Nothing is said about the IVDR, which would certainly benefit from a year breathing space as well, as MedTech Europe remarked very rightly in my view.

What will the status of the AIMDD and the MDD be during the postponement year? We don’t know. I have heard the first suggestions that the notified bodies will not continue to accept conformity assessment requests under these directives (in so far they were still doing that). You can also not automatically count on ongoing conformity assessments or remediations to be allowed to stretch pas the date of application. It would be welcome and logical if this would happen, but we will not know before we see the text of the proposal.

What about Brexit, Swixit and Turkxit?

If the MDR would be ‘postponed’ by a year in a way that the directives continue to be in force, then the logical consequence would be that Swixit and Turkxit are postponed too, because under the directives Switzerland and Turkey are Union, and will thus remain Union until the MDR becomes applicable one year later.  But this does not mean that the root causes for Swixit and Turkxit will be remedied during this year, as these are very political problems.

Brexit is different because the UK has opted to cease being Union by the end of the year no matter what, so this will not change as a result of the MDR’s date of application being moved. This would only change of the UK and the EU decide to together to prolong the transitional period with one or two years. This is politically difficult in the UK because prolonging the transitional period means that EU law applies longer in the UK and the UK has to contribute to the costs of the EU. The UK government has already stated in no uncertain terms this is not what they are planning to do. In other words, Brexit is likely not impacted by this – it still looks like an unfolding hard Brexit happening.

What don’t we know now?

Well, most importantly: we do not know what the proposal looks like. We also do not know if this will even work. That’s why we need to wait until early April to know what the proposal will really entail.

In the mean time, we also don’t know if the proposal will make it, so we have to plan for that eventuality as  well.

What should you do?

This is a plan of the Commission, not an adopted amendment yet. We hope it’s a silver bullet but we do not know yet. It might even be a lead bullet.

As I have said and will keep repeating: scenarios, scenarios and more scenarios. It may be that this whole thing does not even pan out. Then what? Better have a scenario. No imagination? I’ll be glad to help you.

What should you not do?

Treat this plan of the Commission as a done deal and immediately sit on your hands. That would be a bad idea.

While the statement says that ‘this decision will relieve pressure […] to fully focus on urgent priorities related to the corona virus’, it is not saying ‘you should just drop all MDR prep work’. The MDR is still coming and you don’t know what this amendment – if it is amended – will look like in all details.

Did I say scenarios already? One of these is that the whole thing does not happen, and some others are that it happens differently than expected.

 

 

 

The MDCG guidance on significant changes – a significant change?

Batman slap significant change

It’s hard to keep up with all the work and the new publications of guidance these days. Abundance creates its own problems one could say, so that’s why this blog was slightly delayed. Due to the COVID-19 epidemic I have had to home quarantine the family, move the whole law firm to a virtual platform and keep up with all the work in the mean time. You know, all in a day’s work.

The MDCG finally published MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD.

This is no small matter because this is perhaps one of the more crucial guidance documents anticipated, because it should clarify the concept of ‘significant change’ under article 120 (3) MDR.

This concept is absolutely crucial for the market to understand. As a result of the scarcity of MDR accredited notified bodies and capacity, the large majority of the market with CE certificates was forced to accept renewal of existing (AI)MDD certificates. This is the only viable alternative to remain able to place products on the market after 26 May 2020, the date of application of the MDR, until 26 May 2024 at the latest. As a result most of the CE certified devices on the market post 26 May 2020 will depend on these certificates until they have been able to replace them with MDR certificates.

There is only one very big problem with this option: the manufacturer cannot implement any ‘significant changes’ because if he does, the (AI)MDD certificate is immediately invalid. Sounds exciting, right? This makes it crucial to know under what circumstances that would happen.

The and/or problem seems to be fixed by interpretation now

We were having the interesting problem that the text of article 120 (3) MDR provides that:

“provided there are no significant changes in the design and intended purpose” (emphasis added)

This use of the operator ‘and’ would suggest that there would only be a significant change when both of these conditions were true, which I and many others have always found an unlikely interpretation. The guidance does not conform this position, but also does not explicitly state that the law has not been drafted in a way that it correctly reflects the legislator’s intention. Rather, the guidance sneakily uses “or” or “nor” instead of “and” throughout, which I am quite willing to interpret as a position of the MDCG that the “and” operator in article 120 (3) MDR should not be read as an ‘inclusive and’ (this is a logic operator that does not exist, and therefore is a pun to make the point). My theory is that the legislator intended to put in a an inclusive logical disjunction (basically an ‘and/or’) rather than just ‘and’ as in ‘both conditions must apply’. Problem solved!

What is not a significant change according to MDCG?

What is not a significant change, according to the guidance? Those are:

  • administrative changes of organisations are considered in principle as non-significant. This includes changes of the manufacturer’s name, address or legal form (legal entity remains) or changes of the authorised representative
  • all changes not having an impact on the design or the intended purpose of the device can be regarded as not significant – this includes relocation or addition of new manufacturing sites, including when it affects subcontractors or suppliers, or of certain changes of the quality management system, provided that the conditions for which the conformity assessment certification was granted are maintained.

And: all changes implemented as a corrective action (see CAMD FAQ, question 17) are not significant changes either, so you can save yourself a lot of problems to have a design change on the basis of a corrective action rather than based on a PMS plan finding that the device could be better. Unfortunately the CAMD FAQ requires

“design changes related to corrective actions assessed and accepted by the Competent Authority”

for this so that seems to refer to an actual incident that needs to have been notified. However, there is nothing to stop you from notifying incidents of course.

How to deal with the no-print problem?

If on the one hand certificates cannot be amended anymore post DoA (this is how the situation was explained by notified bodies and authorities) because ‘no new certificates can be printed’ post DoA, how to deal with the fact that non-significant change are still allowed? This is also explained in the guidance:.

“The notified body that issued the AIMDD or MDD certificate may confirm in writing (after having reviewed manufacturer’s description of the (proposed) change) that the implementation of the change does not represent a significant change in design or intended purpose under MDR Article 120(3) and that the related AIMDD or MDD certificate remains valid after the date of application of the MDR, but no longer than its expiry date or 26 May 2024, whichever comes first. Such written confirmation corrects or complements information on an existing certificate but does not represent the issuance of a “supplemented certificate” as this is prohibited as mentioned in Section 3. In case of requests from authorities the manufacturer should number such letters received from the notified body and submit them together with the certificate.”

For class I manufacturers under 120 (3) with DoCs:

“In relation to class I medical devices requiring the involvement of a notified body for the first time, manufacturers of such devices must be able to justify their decision when the changes are considered to be non-significant. The justification shall be documented and made available when requested.”

The flow of significance

The

“guidance document provides in its Annex several flowcharts based on NBOG’s Best Practice Guide 2014-3: “Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System”. In particular, Chart C, which is specific to software, draws inspiration from Annex VI, Part C, section 6.5 of the MDR to identify modifications that are considered as significant change in (software) design.”

The guidelines contain flowcharts for determining if a change is significant for the following scenarios:

  • Change of the Intended Purpose (chart A)
  • Change of the Design or Performance Specification (chart B)
  • Software Change (chart C)
  • Change of a material (chart D)
  • Change of terminal sterilization method of device or packaging design with impact to the sterilization (chart E)

These charts are applied after application of the main chart in the guidance that shunts the question to one of the charts A to E.

The charts are very similar to the same as those in MedTech Europe, COCIR and some others’ Joint Industry Position on Significant Changes According to MDR Article 120(3) dating back to February 2019, and even the text is largely identical. We have also seen these flowcharts in LNE/G-Med’s guidance on significant changes of April 2019.

This means that it took the MDCG more than a year to basically endorse a ready made industry position presented on a silver plate and add a little text of its own. This is … disappointing.

Yet, there are small differences between the Joint Industry Position and the MDCG guidance in the flowcharts, so these are not applied identically. I have not taken the time to check all of these, but I advise you be aware of them and review your procedures carefully if you’ve set them up based on the industry position paper.

How now, and: ‘significant’ is not ‘substantial’

There seems to be a lot of confusion in the market between what a ‘substantial change’ is (in the meaning of NBOG 2014-3) and a significant change in the meaning of article 120 (3) MDR. Although they look similar, they are really different and although the guidance does not specify this explicitly, it shows that they are different. The easy way to understand the difference is as follows:

  • substantial changes are things you have to inform the notified body about, so they can assess the consequences for the CE certificate; while
  • significant changes are substantial changes that cannot be implemented anymore because article 120 (3) MDR says so – well, you can implement them but this invalidates the certificate, which is what nobody aims for as a result I assume.

For me the importance of the new guidance was in section 4, which describes how to work with the notified body. Conversely, it also expresses the expectations of how the MDCG expects the notified bodies to handle manufacturers, which is very important too as notified bodies are not always that good with good administrative practices that we would expect from bodies charged with state authority. This is needed because the MDR contains precious little in actual notified body procedure requirements regarding legal recourse, because the incongruence between protection against government agencies and notified bodies has always been and remains one of the issues I struggle with as a lawyer. I see some of notified bodies do things we would never (and should never) accept from a government agency in terms of good administrative procedure.

The guidance provides in this respect:

“In line with agreed arrangements for notification of changes between the manufacturer and the notified body according to the AIMDD/MDD (e.g. contractual relationships, approved procedures) changes and their implementation will be verified by the notified body as part of the surveillance activities, or following a manufacturer’s submission for prior approval. The outcome of this verification will determine whether a certificate in accordance with AIMDD/MDD remains valid according to Article 120 MDR.”

“Nevertheless, such changes continue to be subject to the agreed notification procedure identified in the first paragraph of the current section. The manufacturer should always remain responsible for providing evidence that all the above-mentioned changes do indeed neither affect the design nor the intended purpose.”

“The notified body that issued the AIMDD or MDD certificate may confirm in writing (after having reviewed manufacturer’s description of the (proposed) change) that the implementation of the change does not represent a significant change in design or intended purpose under MDR Article 120(3) and that the related AIMDD or MDD certificate remains valid after the date of application of the MDR, but no longer than its expiry date or 26 May 2024, whichever comes first. “

How will this play out in practice when manufacturer and notified body disagree? It would have been really nice to have some guidance on that. For example, can a notified body just declare the certificate invalid in a disagreement with the manufacturer? Will competent authorities take an active role in arbitrating such differences? I think they really should actually.

No guidance on other aspects of article 120 (3) MDR

The guidance does not provide any clarification of other aspects of article 120 (3) MDR that I receive more and more questions about, e.g. whether the economic operator provisions in articles 13-16 also apply to (AI)MDD governed devices in scope of article 120 (3) MDR. Not everybody agrees on this, and there is considerable controversy about this in the market.

Significant changes and M&A

This subject warrants a blog post in itself and this is forthcoming, but I will still give you some ideas here in this presentation at the RAPS Convergence conference last year:

In my experience, most M&A projects and subsequent integration will almost always involve one or more steps that would give rise to a significant change under article 120 (3) MDR.  That means that if you are selling or buying a devices company with certificates or DoCs profiting from article 120 (3) MDR transition understanding this is one of your top priorities. Getting this wrong means invalid certificates and/or declarations of conformity that need to be replaced by MDR certificates and DoCs, which will take a long time and will be costly to remediate. In the very best scenario it will be very costly and will affect the rationale of the deal considerably or even invalidate. Better think about that in advance because I assure you that your legal department (which is usually not that knowledgable about this kind of regulatory detail stuff) will not. I’ve seen that happen dozens of times by now.

Not the IVDR!

This guidance is only for the MDR (not a single reference to the IVDR). Yet, the IVDR contains a regime identical to that of article 120 MDR in article 110 IVDR. Should we now draw the conclusion that this can be interpreted identically as set out in this guidance? Probably not, because the flowcharts mostly address typical MDR subjects, except for chart C (software changes).

But what about the body of the guidance – that is relevant to the IVDR too, right? Well, we don’t know. It sounds logical that it would and it would even be a small effort for the MDCG to make a small remark to that effect. But they didn’t.

Like I’ve observed in the recent blog about the Joint Implementation Plan: IVD industry, you’re on your own for the moment. The MDCG is not thinking about you at all for the moment.

The MDR and the Covid-19 recommendation – a possible template for fixing the MDR and IVDR bottleneck

problem-solved-spongebobOn 16 March 2020 the Commission published the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat.

While this recommendation has been flagged here and there as ‘this may be important’ without real further comment I have been thinking about this recommendation myself and here is my take on what it means and may lead to.

What is this recommendation about?

Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a template for the next pandemic that has already started to affect the medical devices industry: the bottleneck caused by date of application of the MDR.

Let’s see what the recommendation does: it addresses two kinds of administrative barriers: conformity assessment procedures and market surveillance procedures.

With regard to conformity assessment procedures the recommendation recommends member states to

“the possibility for Member States to authorise derogations from conformity assessment procedures should also be considered, according to Article 11(13) of Directive 93/42/EEC and Article 59 of Regulation (EU) 2017/745 once the latter becomes applicable, also when the intervention of a notified body is not required.”

In other words: please Member States, think about your options to propose national CE marking exemptions for devices that can be transformed into a pan-European measure by means of the article 59 MDR procedure. The Commission cannot take its own initiaves on this point but can recommend the membe states to do this. Article 59 MDR procedure allows the Commission to make measures taken by one member state mandatory for the whole Union, which is a pretty useful feature. If one member state decides to allow a device on the market without CE mark and notifies the Commission, the Commission can validate the exceptionality and need of the measure at Union law and make an implementing act to make the measure mandatory for the whole Union, which becomes applicable after the members states and the EU parliament allow it through the implementing act procedure.

With regard to market surveillance the recommendation recommends member states to:

  1. The relevant market surveillance authorities in the Member States should as a matter of priority focus on non-compliant PPE or medical devices raising serious risks as to the health and safety of their intended users.
  2. Where market surveillance authorities find that PPE or medical devices ensure an adequate level of health and safety in accordance with the essential requirements laid down in Regulation (EU) 2016/425 or the requirements of Directive 93/42/EEC or Regulation (EU) 2017/745, even though the conformity assessment procedures, including the affixing of CE marking have not been fully finalised according to the harmonised rules, they may authorise the making available of these products on the Union market for a limited period of time and while the necessary procedures are being carried out.
  3. PPE or medical devices not bearing the CE marking could also be assessed and part of a purchase organised by the relevant Member State authorities provided that is ensured that such products are only available for the healthcare workers for the duration of the current health crisis and that they are not entering the regular distribution channels and made available to other users.

The first point addresses dangerous non-compliant devices. I already see a spike in placebo medical devices and non-compliant Covid-19 self tests of which nobody knows where they come from or whether they even work for this intended purpose. Needless to say, authorities should clamp down on those.

The second point seems to be a reference to the article 97 (3) MDR procedure, under which the Commission can specify appropriate measures by implementing act for devices that are non-compliant administratively but do not present an unacceptable risk to health and safety of patients. This is an interesting procedure because unlike the article 59 procedure it allows for block exemptions.

The third option is also a good option: member states allow devices purchased according to certain specifications for the duration of the health crisis. This works especially well when devices are purchased via tenders.

So this recommendation, if you realize the at the Commission does not have any direct power under the MDR to take emergency measures, is really something. But it can also be a stepping stone for the way the EU handles the consequences of the bottleneck in medical devices approval caused by the way the MDR was set up, and which is now compounded by the Covid-19 health crisis.

What does/could this mean for the MDR and its date of application?

Everybody and their mother wants the date of application of the MDR moved for obvious reasons – with the Covid-19 pandemic happening notified body capacity is collapsing, and manufacturers have facilities closed down so are unable to receive physical audits. Even though everybody does what they can remotely, the processes are even more delayed and are delayed severely. We may not even out of lockdown in many place by the DoA of 26 May 2020.

The DoA, abbreviation for Date of Application, is starting to be cynically used as ‘Dead on Arrival’ by now. The situation is really getting out of control, even if everybody, including notified bodies, are doing their best to keep working the problem.

Yet, there is no mechanism in the MDR for moving up the DoA quickly because the EU is not set up this way. Clamoring for that is therefore not going to work.

A change of the DoA requires a legislative change, which cannot happen quickly. Reopening the MDR would lead to a situation where everybody would propose amendments or disagree, and that would bog down the process even more. Even if everyone agrees and does not propose amendments, the process takes several months. So that won’t work anymore now.

Emergency measures then? Since the EU is not a federation we have not delegated that much in terms of actual decision making power to the EU institutions, especially not in healthcare. The Commission is allowed to propose and the EU may adopt internal market measures that have a health dimension, but it is totally not allowed for the EU to intervene in emergency health situations on its own initiative with binding measures. Member states closely guard their national competence in that field and are not going to hand that over to Brussels. This pandemic shows that doing exactly that may not be such a bad idea – as they say, never waste a good crisis.

All emergency procedures in the MDR therefore start with a member state or an MDCG initiative, which is subsequently made binding by the Commission with an implementing act. The implementing act can always be blocked by member states or the Parliament. So this is how the EU works: nothing happens unless everyone agrees. Usually this works fine. In pandemics, it’s not so efficient.

The only way to move the MDR date of application is to start a new legislative procedure and change the date of application. Nobody wants to start a new legislative procedure at the moment however. Why? Because first, it is a slow process. Secondly, everybody will put in amendments because they can, slowing down the process enormously because nobody is going to agree with the amendments of everybody else just like that.

My thinking is that a version 2.0 of this recommendation would solve a lot of problems, without needing to go through a legislative procedure to amend the MDR. It would be appropriate too, because the Covid-19 pandemic and the date of application overlap and compound issues. Many of the bottleneck problems that we were having already with respect to notified body capacity have been steeply exacerbated by the Covid-19 pandemic.

A new recommendation drafted with the date of application in mind could provide the necessary coordinative template for member states to solve the unavailability of safe devices as a result of administrative problems, because the Commission does not have the power to do this. The recommendation 2.0 would provide a template for concerted and efficient use of the article 59 and 97 (3) MDR procedures. Everybody wins and the patients the most. Would’t that be great?

Again, why not the IVDs?

As we have seen with the Joint Implementation Plan, this Covid-19 recommendation also does NOT apply to IVDs – it only mentions medical devices under the MDD and the MDR. I don’t understand how you can ignore IVDs when the whole healthcare system is complaining about a lack of tests? In any pandemic, access to sufficient relevant tests is vital. I can for the life of me not understand how it is possible to ignore IVDs in this scenario.

Any recommendation 2.0 aimed at fixing the medical devices bottleneck should address IVDs too. The writing is on the wall that the bottleneck will be far worse for IVDs

A little side note on standards

Everybody is frustrated about the delay in harmonised standards for the MDR and IVDR, but this is no reason for delay as such. The recommendation reiterates in recital 18 that

compliance with the harmonised standards is not mandatory. Manufacturers are free to choose other technical solutions provided that the specific solution which is retained ensures that the medical device complies with the applicable essential health and safety requirements.”

So, absent the harmonised standards manufacturers must think about what the state of art really is, and how a GSPR can really be met by their solution. Good time to think out of the box. The recommendation impresses in recital 22 on notified bodies to be flexible in this, and not be hung up on standards per se.

So – outlines of a way out

Use the recommendation 2.0 route could be the best compromise under the circumstances – a tried remedy that everyone should be able to live with and has a good chance of solving a lot of problems related to the conformity assessment bottleneck exacerbated by the Covid-19 pandemic. A true European solution! Now we just have to do it.

New MDCG Class I Article 120 (3) and (4) MDR guidance – nothing new but nice summary of requirements

Class I guidance gullI have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described. 

The new guidance

The MDCG has now (finally) published its guidance MDCG 2020-2 on the subject, which confirms everything in that blog in terms of the mechanics of timing, but adds important procedural requirements for a class I manufacturer about how to actually document things, what the state of the technical file and QMS should be and what the declaration of conformity should look like, because these are things that manufacturers of class I devices often do not right.

Contents of the declaration of conformity: guidance on the content of the Declaration of Conformity can be found, inter alia, in the “The ‘Blue Guide’ on the implementation of EU products rules 2016 (2016/C272/01)” and the standard EN ISO/IEC17050-1. That guidance was always there already (and this is yet another reason to read the Blue Guide, which everybody should do – it contains many of the answers that people keep asking me).

If you do amend your technical documentation and/or DoC, mind you that 

“Necessary amendments/updates to the technical documentation should be done in a transparent manner. Both the changes and the dates of when the changes were made should be recorded. On the basis of the Declaration of Conformity and the corresponding technical documentation, the manufacturer should be able to demonstrate that the Declaration of Conformity was lawfully  issued before 26 May 2020 and that, subsequently, there are no significant changes in the design or intended purpose in the meaning of Article 120(3) MDR.”

Also this requirement should not be a surprise, but here you have it again.

For whom?

For which manufacturers is this important? This is important for all manufacturers whose medical device would be up-classified under the MDR, such as including but not limited to (standalone) software, substance based devices and inhalers.

Can’t figure it out? This is the moment to dare to be wise and really understand this stuff, or ask someone to help you understand. That could be me or any other good medical devices expert out there. It’s busy times though as you may have noticed, so ask sooner rather than later. 

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