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MEDICALDEVICESLEGAL
Medical devices legal and regulatory blog
* About Erik Vollebregt
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 paperCommentsIncrease notified bodies’ capacities
1. MDCG advises notified bodies to make use of hybrid auditsIt 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 RegulationsIt
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.
NO DEROGATIONS
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.”
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