Update on MDR/IVDR trilogue

keep-calm-it-will-happen-14The trilogue has been quietly progressing, with a view to being concluded for this Presidency at the EPSCO meeting of the Council on 8 December after a final trilogue meeting planned on 3 December. That is, for this Presidency (the Luxemburg one). If the  Commission, Parliament and Commission do not manage to reach consensus on everything, the trilogue negotiations will continue under the Dutch Presidency in the first half of 2016. If that happens, the expected date of entry into force of the regulations may also move into the second half of 2016. It also looks like the housekeeping necessary for publication of final texts after a successful trilogue will take more time than expected (implement all agreed compromises in 400+ pages of legal text, peer review it and translate that into 20+ languages) in that it may take several months.

While the trilogue meetings are completely closed door and therefore black box, there are some things that are being heard in grapevines. So far it’s slow going on reaching consensus and from what I understand there seem to be especially divergent positions on the subjects of liability, transparency, reprocessing and hazardous substances regulation. This is just what I’ve heard indirectly, not verified at the source, and my perspective on these subjects.


Liability is a tricky one, because it’s about the proposals to include additional liabilities in the regulations for authorized representatives, manufacturers and notified bodies. I am getting a lot of signals about how this will impact these actors. ARs and notified will go out of business as they cannot afford the insurance cover required (except the very big ones); which may be the same for smaller manufacturers. Everybody will seek to pass on these costs and/or liability, so the net result is that devices will become more expensive while lawyers and insurance companies will be very happy and thrive. Mandatory insurance cover as such, in my opinion, has never made things better for patients because insurance companies are not in the business of paying out money, but doing that as conservatively as they can get away with. The only reason to do this right for patients is to harmonize the criteria under which a fight about liability can never be the patient’s problem (which, of course, was not considered in any of the amendments).


Transparency is about what will go into the Eudamed database and what levels of access will apply for what categories of users. It concerns for example the debate if all adverse events need to be reported or only serious ones, which will make a lot of difference in terms of regulatory burden. There is also serious doubt about whether the competent authorities even have the resources to do a meaningful review of all that data.

It’s also about the proposal of the Parliament to include transparency for clinical investigations data like the EMA is currently implementing and I understand this is a very important point for Ms Willmott, the ENVI Committee rapporteur, who was rapporteur for the clinical trials regulation for medicinal products.

This would have big consequences for the medical devices market because it will likely create an instant market for generic medical devices without any of the regulatory protections that medicinal products have. The result will be a situation where innovative medical devices companies will be more than reluctant to invest in expensive clinical investigations because their results will be on the street immediately upon obtaining a CE mark, allowing competitors to follow up with a “me too” product quickly and efficiently.


Reprocessing is politically volatile because of the very different member states positions on the subject and the polarized Parliament position (“single use labeling is like printing your own money“) which may (hopefully) be less polarized under the new ENVI Committee rapporteur for the MDR.

Hazardous substances

Hazardous substances regulation is a not that well considered Parliament amendment that is very controversial to industry as it overlaps with current regulation and the sweeping phase out requirements would lead to widely relied on medical devices needing to exit the market with no alternatives being available currently.

Reclassification of substance based devices

This is mainly about the famous Rule 21, the new classification rule for ‘substance based devices’ (‘devices that are composed of substances or combinations of substances that are intended to be ingested, inhaled or administered rectally or vaginally introduced into the human body via a body orifice, or applied on skin and that are absorbed by or locally dispersed in the human body’) which will be upclassified considerably, sometimes from class I to class III. This will of course impact industry that produces these product enormously.

Quo vadis trilogue?

The above four issues were controversial up to now but other and additional potentially controversial subjects are still to be discussed in the upcoming trilogue meetings because we are only halfway in the trilogue agenda, such as notified body oversight and organisation (e.g. will there be special notified bodies or not). Since these meetings are as closed as they can be, it’s difficult to know what’s really going on and every statement in that regard is speculative.

Next formal public update will be at the next EPSCO Council on 8 December – we will likely know then whether the trilogue was successful during the current Presidency.

Update! White paper on MDR / IVDR updated

13_img0_BSI Core LogoIn March 2014 Gert Bos (Head of Regulatory and Clinical Affairs at notified body BSI) and I wrote a white paper on the new EU medical devices and IVD regulations in the legislative procedure. It was well received and as the legislative procedure for the regulations progressed there has been an increasing demand for update of the white paper.

Updated white paper

That update is now available and you can download it from here. The updated white paper reflects the situation as per the start of the trilogue beginning of October this year (5 October EPSCO meeting), so it takes the last publicly available Council proposed text into account. Like the previous version we hope that it will be of use for everyone!

More white smoke – trilogue for MDR and IVDR in progress

keep-calm-it-will-happen-14White smoke again! After a long summer following the partial general approach on 19 June in which there was not much to report the Council now reached a general approach on the MDD and IVDR on 5 October, endorsing its negotiating position on the medical devices and in vitro diagnostic medical devices draft Regulations. The Council’s decision allows the Luxembourg presidency to start the ‘Trilogue’ talks with the European Parliament and the Commission with a view to reach an agreement as early as possible – the first meeting took place on 13 October, but since the Council is not publishing these reports, we don’t know the result publicly yet.

I know what they did last summer

What happened over the summer? Remember, we only had a partial general approach before the summer. In the words of the Council in the A item note:

“5. At its meeting on 23 September 2015, the Permanent Representatives Committee (Part 1) examined the draft Regulation on medical devices set out in document 12040/1/15 REV 1+ ADD 1 and the draft Regulation on in vitro diagnostic medical devices set out in document 12042/15 + ADD 1 and noted that the Working Party on Pharmaceuticals and Medical Devices had reached agreement at technical level on recitals that reflect the contents of the two draft Regulations and on corrections of technical inconsistencies.
6. At that meeting, it was noted that all delegations apart from the German delegation could support the two texts referred to in Point 5. A qualified majority in favour of the draft General approaches therefore exists.”

The regulations with recitals (those were missing on 19 June) are now public:

MDR + annexes (over 400 pages together)

IVDR + annexes (over 350 pages together)

There have been some later very technical iterations that modified details between these texts and those finally agreed as general approach, see e.g. here for MDR, MDR annexes, IVDR and IVDR annexes. However, those texts are not public.

German objections

The story doesn’t tell whether the Germans overcame their objections, but this was irrelevant in the end since the qualified majority of member states rallied against them could overrule them and escalate the dossiers to the trilogue. Given that only the Germans were objecting I suspect the issue was with other member states’ tweaking in the German themes, likely reprocessing of single use devices, which many member states have issues with and the Germans are currently already allowing.

The technical corrections and recitals are published now, but the technical corrections in the annexes are not groundbreaking (that’s why they are technical corrections and not substantive ones).

Industry still cautions

Eucomed notes that there are still 5 areas that need attention during the trilogue:

  1. The ‘Scrutiny’ mechanism – Redundant with other improvements, but if there, at least make it workable and predictable
  2. Clinical evidence – Maintain the Commission’s and a much simplified Council case-by-case approach and get the definitions of clinical data and clinical equivalence scientifically sound
  3. Re-use of single-use medical devices – Ensure a single high harmonised level of safety across the EU as per Commission proposal with hospitals and subcontractors appropriately covered
  4. Hazardous substances – Support the feasible, scientific and proportionate approach of the Commission
  5. Unnecessary added complexity and disproportionate measures – Strip out unfeasible, disproportionate or duplicative requirements and reverse unjustified re-classifications

These points are clarified in a convenient position paper that you can find here and which provides alternative proposals as stakeholder input for the trilogue.

EDMA provided a similar position paper, flagging 6 areas in the IVDR that need attention in the trilogue:

  1. Clinical Evidence requirements must be adapted to the specificities of IVDs, and be broadly appropriate for all IVDs, not just companion diagnostics and interventional technologies, which make up only a few percent of all IVD products. Acknowledging this is especially important when defining requirements for studies, post-market assessment, and criteria for assessment of IVDs.
  2. Conformity Assessment should reflect the risk-based approach with proportionate regulatory controls increasing alongside the risk class.
  3. Quality Management Systems should establish only those requirements applicable and feasible for IVDs, as opposed to those applicable for other health technologies. In addition, specific IVD technology and requirements (e.g. self-tests) should adequately reflect the nature of these devices.
  4. The Companion Diagnostics definition is not specific enough and should only include those IVDs selecting patients for a specific therapy. In addition, the mechanism for clinical evidence requirements for companion diagnostics, especially scientific validity and intermediate assessment, must be adapted.
  5. Classification principles for IVDs must be consistently applied to ensure a system of controls that is proportional to the risk class of the IVDs, while at the same time adhering to the internationally agreed classification scheme.
  6. Labelling Requirements need to be clear and uncluttered, focusing on the information that is essential for the safe use of the IVDs to deliver relevant results and adhering to globally harmonized labelling requirements.

The EDMA position paper clarifying these areas can be found here.

What’s next?

The trilogue will unfold during the Luxemburg Presidency during the last half of 2015 and if this all goes well, there will be a compromise text that the Dutch presidency will be able to shepherd in becoming law somewhere in the first half of 2016.

As industry’s reactions show, things may still shift in the positions as each of the institutional actors has their hobby horses in the respective texts, like e.g. reprocessing for Germany, centralization of governance and market surveillance for the Commission, PMA on the extremely regulated end of the spectrum for the Parliament and national exemptions for this, that and the other thing by the Council.

But that’s not all

Meanwhile, the General Data Protection Regulation and the NIS Directive are also nearing completion of their respective trilogues. As I have blogged in the past, both of these regulations (especially the GDPR) will have severe consequences for how (international) medical devices companies do business and design their devices and IT solutions. Good luck with your implementation for these two as well.

White smoke: we have a general approach for the medical devices and IVDs regulations

Schermafbeelding 2015-06-21 om 19.28.23

Yes, finally!

Yes we can! We have a general approach for both the Medical Devices Regulation and for the IVD Regulation, agreed in the EPSCO Council last Friday.

The press release also conveniently bundles all the general approach texts.

Although the Council statements by the member states during the meeting left a lot of question marks as to what was going to happen, the Council still managed a partial general approach in the end.

The general approach is partial because the Council still has not agreed on the recitals to the regulations and there are still some technical inconsistencies to be ironed out. If you are interested in the full debate, here is the video of the whole session.

The Latvian presidency was visibly relieved at the end of the meeting, having finally crossed the finish with its wheelbarrow of frogs. That doesn’t mean that everybody was happy though.

Cost and complexity

One of the general concerns that was consistently voiced were the costs and complexity of the system set up with the compromise, and the need to keep that under control. It’s interesting how politics always seem to take place in a universe parallel to reality, because this is something that industry has been raising awareness about for almost three years now. I guess it seems more opportune to first set up a complex and costly system while ignoring signals to the contrary before starting to wonder whether the system is not getting to complex and expensive, and then be forced to deliver a system validated only by confirmation bias.

MedTech Europe, important voice of the EU medtech industry, was not completely happy with the results, flagging a number of points in both regulations that will still need work in the trilogue (see here for more detail):

  1. the scrutiny mechanism (still too complex and too slow);
  2. reprocessing of single use devices (different levels of safety depending on who is the reprocessor (original manufacturer, commercial reprocessor or hospital reprocessed));
  3. clinical evidence for IVDs (clinical evidence burden raised too much compared to Commission proposal); and
  4. companion diagnostics definition (too broad to be functional)

Several member states also made it clear that while a compromise was reached because they wanted to be ‘constructive’ but not because it made them happy so that they will still push the points that they were not happy with.

Peter Liese, the rapporteur for the IVD regulation was not happy either and stated in the mean time that the Parliament thinks that the Council’s text needs improvement and still seems to stick to the unconstitutional genetic testing proposal.

Unhappy member states and unhappy Parliament means that the Parliament and the member states concerned may seek to exploit the loose ends in the negotiations that follow in the trilogue and may form (unexpected) coalitions to score the occasional points in the political process where there is overlap.

What’s next now?

According to the Council’s press release:

“The agreement on the substance of the Council’s negotiating stance will allow the next presidency to take contact with the European Parliament to prepare negotiations between the two institutions. Once the Council has finalised some outstanding technical work concerning the preamble of the two draft regulations, negotiations between the institutions will be able to start.”

For the subsequent timeline see my earlier blog on the MDR text. There are no indications as yet that this would change.

More on scrutiny in the general approach proposals for medical devices and IVDs

380px-EU_Consilium_Logo.svgUpon closer examination of the two texts for the MDR and IVDR it became clear that the scrutiny proposals in both regulations are actually identical (sorry for the earlier confusion).

Accordingly, there are two novelties.

Largely the same

First, things unexpectedly stay largely the same both under the MDR and IVDR: pre-market evaluation by a notified body and post-market controls by the authorities. This is definitely a novelty because this was not the expected outcome.

The member states have apparently been able to agree that the current quick market access procedure in the EU has served the market very well and that a more front loaded pre-market process does not produce safer devices, as has been recognized also in pharma market access.

Of course we will need to see if this holds up during the trilogue with the Parliament.

Validation of clinical strategy by expert panel

Secondly, the novelty in the market access procedure for medical devices is the possibility for class III devices manufacturers to submit their intended clinical development strategy and proposals for clinical investigation(s)  to an expert panel for consideration (article 49 (1a) MDR).

The only disincentive to do this is that on the one hand the manufacturer shall give due consideration to the views expressed by the expert panel and must document the panel’s considerations in the clinical evaluation report, while on the other hand the manufacturer cannot may not [that’s what the text says] evoke any rights to the views expressed by the expert panel with regard to any future conformity assessment procedure.

While a notified body can diverge from the expert panel findings later in the conformity assessment procedure, it has to provide justification for this when it notifies the certificate and this is basically the only guarantee that the manufacturer has that the notified body will follow the clinical strategy validated by the expert panel.

Yet, this is an improvement over the current situation where I regularly see notified bodies move the clinical goalposts after the notified body has agreed with the manufacturer on a clinical strategy and even after the manufacturer has already started trials based on that agreement. This puts especially start-up companies in sometimes extremely problematic situations, e.g. when they lack funds to perform the additional trials and go bankrupt.

It would be nice if the expert panel’s evaluation of the strategy would carry more mandatory weight for the notified bodies, because it would make relying on it more attractive for the market, which will lead to a harmonization of clinical evidence for class III devices that everybody should want, including manufacturers (as they hate to see competitors with a better deal on clinical evidence for the same product).


The Council’s IVD regulation proposal for the general approach

380px-EU_Consilium_Logo.svgAs promised yesterday, here is a first impression of the IVD Regulation (IVDR) proposal that may lead to a general approach this Friday in the ESPCO Council.

In this post I will try to not repeat what I have blogged about yesterday given the large amounts of overlap between the two regulation proposals. Where things are the same under the IVD regulation proposal I will refer to the post on the Medical Devices Regulation (MDR) of yesterday.

By the way, the Annexes to both regulations have also become available in the mean time, see here for MDR and here for IVDR. So we have the whole picture now minus the recitals, but unfortunately I do not have time anymore to plow through 300 pages of annexes and produce a coherent blog about it this week.

The Dutch Minister of Health has written in the annotated agenda for the EPSCO meeting that there was much progress under the Latvian Presidency, that the Netherlands see achievement of the general approach on Friday as ‘a very realistic possibility’ (that’s Dutch political understatement for “this will work unless something very unexpected happens”) and that the large majority of the member states supports this (the MDR and IVDR) proposal currently on the table. She also confirms the timetable that I have mentioned as realistic and that it is likely that the Dutch Presidency will complete the project in an early second reading in the first half of 2016.

Chapter I Scope

Same provisions on national competence and freedom of information as in the MDR feature in the IVDR.

There is a new limb to the definition of IVD: “providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.”. This information has to be for medical purposes (given the Commission’s amended definition) but not necessarily for diagnosis, prevention, etc.

A new borderline clause is setting out that “Products specifically intended for the cleaning, disinfection or sterilisation of medical devices and devices for the purpose of control or support of conception shall be considered medical devices.” 

The definition of accessory is not changed as in the MDR and only the word “assist” has been struck out. I assume that this is an oversight as the concept of accessory should be consistent between the two regulations.

The definition of companion diagnostic completely changed to “a device which is essential for the safe and effective use of a corresponding medicinal product to:

– identify patients who are most likely to benefit from the medicinal product, or;

– identify patients likely to be at increased risk for serious adverse reactions as a result of treatment with the medicinal product, or;

– monitor response to treatment by the medicinal product for the purpose of adjusting treatment to achieve improved safety or effectiveness;”

That definition copies the FDA definition and description of a companion diagnostic device almost completely except for the limb

  • “Identify patients in the population for whom the therapeutic product has been adequately studied, and found safe and effective, i.e., there is insufficient information about the safety and effectiveness of the therapeutic product in any other population”

New definition of ‘kit’ as “a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof; ” This will be the IVD counterpart of the new ‘procedure pack’ under the MDR.

‘Safe’ under the MDR is ‘safety’ under the IVDR, otherwise the same definition. Definitions of risk and risk-benefit determination and definitions of compatibility and interoperability;

Refurbished definition of clinical evidence [bold indicates addition]: “clinical data and performance evaluation results pertaining to a device of sufficient amount and quality to allow a qualified assessment of whether the device achieves the intended clinical benefit(s) and safety, when used as intended by the manufacturer”

Identical mechanism to the MDR for Commission decisions in borderline cases.

Chapter II Making available of devices, obligations of economic operators, CE marking, free movement 

The IVDR regime for in-house developed tests is now rather similar to the MDR home brew devices (surprise surprise) regime in its logic that the health institution establishes in its documentation that it has given due consideration as to whether the target patient group’s specific needs cannot be met or cannot be met at the appropriate level of performance by an equivalent device available on the market. There are additional controls for class C and D IVDs.

Like for the MDR there are more prescriptive rules for risk analysis and clinical evaluation (article 8 (1a) and (1b)) and for quality systems (article 3 (5)) and instead of mandatory product liability insurance proposed by the Parliament the Council proposes only a duty to consider insurance (article 8 (11)) – the Parliament was however very adamant on its proposal.

Same articles on authorized representative, qualified person and the same provisions on MAID as in the MDR.

Removal of article 18 about systems and procedure packs. This provision was apparently intended to harmonize current article 12 of the Medical Devices Directive to the IVD Regulation (there is currently no similar provision in the IVD Directive) but the Council will have none of it for IVDs. Apparently this is because the new definition of “kit” is included in the definition of IVD, and, consequently, all kits are to be treated as IVDs in their own right.

Chapter III Identification and traceability of devices, registration of devices and of economic operators, summary of safety and performance, European databank on medical devices

Identical to MDR.

Chapter IV Notified Bodies

Identical to MDR.

Chapter V Classification and conformity assessment

Scrutiny for IVDs (article 42): interesting change compared to the Commission proposal and to the MDR. Scrutiny still applies only to class D devices but the whole MDCG procedure proposed by the Commission is deleted, to be replaced by a notification procedure on a national level. Basically, the notified body notifies the granted certificate for a class D IVD together with assessment report and lab tests and that’s it. If there are concerns that the notified bodies are doing a bad job, “a competent authority and, where applicable, the Commission may, based on reasonable concerns, apply further procedures according to articles 33 [notified body oversight], 33a [new article on competent authority review of technical and performance evaluation documentation], 34, 35 [notified body oversight], 67 [Evaluation regarding devices suspected to presenting an unacceptable risk or non-compliance] and, when deemed necessary, take appropriate measures according to Article 68 [Procedure for dealing with devices presenting an unacceptable risk to health and safety].” This is a big deregulation step for IVDs.

Like under the MDR, notified bodies may impose restrictions to the intended purpose of a device to certain numbers or groups of patients or require manufacturers to undertake specific post-market clinical follow-up studies pursuant to Part B of Annex XIII (article 43 (2a)).

Improvement of certificate of free sale provision: the authorised representative can now also request it, which is helpful because in the Commission proposal these certificates could only be requested by manufacturers established in a member state (article 46), which is kind of discriminatory.

Chapter VI Performance evaluation and performance studies

The IVDR will feature performance evaluation that is mandatory for all IVDs, which looks a lot like clinical evaluation for ‘general’ medical devices, and which is the basis for the clinical evidence for the IVD (article 47).

Performance studies regime significantly amended – subject to IVD Regulation studies regime:

(a) where invasive sample taking is done only for the purpose of the performance study

(b) where it concerns an interventional clinical performance study as defined in Article 2(37)

(c) where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies

(d) in case of performance studies involving companion diagnostics.

Otherwise similar to MDR clinical investigation regime.

Chapter VII Post-market surveillance, vigilance and market surveillance

Similar to MDR. Manufacturers of class C and D devices have to submit PSURs directly to the notified body that will evaluate them.

Chapter VIII Cooperation between Member States, Medical Device Coordination Group, EU reference laboratories, device registers

At the request of a Member State, the Commission may also designate EU reference laboratories where that Member State wishes to have recourse to such a laboratory to ensure the verification of the compliance of Class C devices with the applicable CS when available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent (article 78 (2a).

Detailed requirements for EU reference labs in article 78 (3a). Not a bad idea because these will play an important role in the application of the IVDR.

Chapter IX Confidentiality, data protection, funding, penalties

Identical to MDR.

Chapter X Final provisions

Similar to MDR. There are minor changes in transitional regime for UDI: for class D devices Article 22(4) [affixing of UDI carrier] shall apply one year after the date of application of this regulation. For class B and class C devices Article 22(4) [affixing of UDI carrier] shall apply three years after the date of application of this regulation (5 years transitional period plus 3 years post application date). For class A devices Article 22(4) [affixing of UDI carrier] shall apply five years after the date of application of the regulation (5 years transitional period plus 5 years post application date).

First impression

Largely the same as for the MDR. For the IVDR specifically there are no shocking broad stroke departures from the Commission proposal for the IVD specific items discussed in this post, except for abandoning scrutiny for IVDs completely in favor of post approval controls, which is basically the current situation. This is probably why the IVDR has been riding the comfortable back seat in the political discussion so far, unless the Parliament rekindles the political circus by sticking to the constitutionally impossible (genetic testing amendment) or the highly inadvisable (changing the definition of medical device to anything with an indirect medical purpose) amendments.

Schermafdruk 2015-06-16 09.14.30That does not mean however that the IVDR as such will not be a very major regulatory change for the IVD industry though, as I have discussed on occasions and as set out concisely in the BSI White Paper that I co-authored. The IVD industry has to start building up performance evaluations for each and every IVD currently on the EU market (no grandfathering!) and for each device to enter the market when the new regulation applies. That will be a really big job and I predict that it will be underestimated by many companies. Remember, 80% of the IVDs are expected to be notified body certified (as opposed to 20% currently) under the new regulation, and that also applies to the IVDs currently on the market. Getting all these devices through that process during the 5 years transitional period will be very difficult – the regulatory quantum leap, as it has been dubbed in the mean time.

Compromise texts for EU Council EPSCO meeting public

380px-EU_Consilium_Logo.svgThe two texts that will form the basis for the Council’s attempt to arrive at a general approach at the EPSCO Council meeting on 19 June that would allow it to start the trilogue have been published for the medical devices regulation proposal and for the IVD regulation proposal.

Only part of the picture

Unfortunately this is only part of the story: the annexes and recitals are still missing. The annexes are obviously very important because that is where the technical and procedural stuff is, but also the recitals are important as these give important clues for interpretation of articles in the body of the regulations.

The documents contain consolidated texts for the Articles of the proposed regulations mentioned prepared by the Latvian Presidency with a view to the meeting and were agreed by the Permanent Representatives Committee in its 10 June meeting. This is certainly progress because the dossier has never been this close to moving on at the end of a recent Presidency that dealt with these proposals. The Latvians really did a splendid political job here.

Note that these texts are still a comparison against the original Commission proposals – I myself have also not done a comparison of these texts against the Parliament’s proposals yet. The Council will only formally start to consider the Parliament’s proposals in the trilogue.

This blog is not comprehensive in that is covers all amendments proposed by the Council. I just cover the things that stand out for me in the Medical Devices Regulation proposal text. I apologise for the level of detail and possibly rambling sentences because I did not have time to write it up more coherently before the EPSCO Council.

Also the IVD Regulation proposal is not covered in this blog. I will do my best to provide an analysis for the IVD regulation proposal too – in any event the Council is in favor of sticking to the Commission proposed five years transitional period –  one of the big points given the Herculian task for industry to move to a situation of 80% self certified devices to 80% notified body certified devices.

Chapter I Scope

Rise of the non-medical devices (Annex XV) – they are in and will be subject to common technical specifications that will be drafted in time and will be subject to criteria analogous to essential safety and performance requirements and clinical evaluation.

There is a new borderline clause for borderline with the Tissues and Cells Directive (article 1 (5a)).

There is an amended clause defining EU competence versus national competence, with the bold font showing the changes (Article 1 (8): “This Regulation shall not affect national laws concerning the organisation, delivery or financing of health services and medical care, such as, the requirement that certain medical devices may only be supplied on a medical prescription, the requirement that only certain health professionals or health care institutions may dispense or apply certain medical devices or that their application must be accompanied by specific professional counseling.”) This would seem to preclude proposals like the genetic testing proposal under the IVD Regulation, which prescribed counseling prior to genetic testing – which colleagues and I argued was out of scope of EU competence all along.

Freedom of information (article 1 (8a – there is a new clause for this, stating “This Regulation shall be without prejudice to national laws regarding public access to official documents and regarding freedom of the press and freedom of expression in other media.)”. This seems to mean that it will become possible to fish for information in Eudamed etc. via national freedom of information legislation insofar as the member state concerned has access to the information.

Accessory definition: the not-so-clear term “assist” has been removed and replaced by “to specifically and directly assist the medical functionality of the medical device(s) in view of its/their intended purpose(s);” (article 2(2))

Standalone software will not automatically be an active device anymore (article 2 (4)) – difficult to see what else it will be then and how rules other than current rules 9-12 could apply, as these are based on degree of invasiveness and area/time of contact with the body, something that software typically does not do.

New definitions:

  • definitions of falsified medical devices, procedure pack and system, non-cellular derivative substance;
  • definitions of performance, safe, risk and risk-benefit ratio;
  • definition of compatibility and interoperability;
  • definition of clinical evaluation: “a systematic and planned process to continuously generate, collect, analyse and assess the clinical data” (article 2 (32));
  • definition of subject, clinical evidence, clinical performance, clinical benefit, investigator, informed consent, and Ethics Committee (article 2 (37a-l));
  • definition of post market surveillance (article 2 (40a)); and
  • definition of serious health threat (article 2 (44a)).

The Commission can now also decide on its own initiative (rather than after request by a member state), after consulting the MDCG, by means of implementing acts whether or not a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory to a medical device’ (article 3 (1a)). This would mean that individuals may petition the Commission to act in these matters but that they have absolutely no legal recourse.

Chapter II Making available of devices, obligations of economic operators, reprocessing, CE marking, free movement

Article 3 (4a) sets out a new regime for home brew medical devices, with many conditions to meet that member states will interpret very differently, like e.g. “the health institution establishes in its documentation that it has given due consideration as to whether the target patient group’s specific needs cannot be met or cannot be met at the appropriate level of performance by an equivalent device available on the market”.

Annex I can now be amended by implementing acts rather than delegated acts (i.e. less formalities).

The Council’s proposal provides for more prescriptive risk analysis and clinical evaluation (article 8 (1a) and (1b)) and for quality systems (article 3 (5)).

Instead of mandatory product liability insurance proposed by the Parliament the Council proposes only a duty to consider insurance (article 8 (13)) – the Parliament was however very adamant on its proposal.

Additional tasks for authorised representatives (article 9 (3)) are featured:

  • verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
  • comply with the registration obligations (laid down in Article 25a(1), (4) and (5));
  • forward to the manufacturer any request by a competent authority in the jurisdiction where he has his registered place of business for samples, or access to a device and verify that the competent authority receives the samples or gets access to the device;

Additional liability for authorised representatives (and this is a big change):

“Without prejudice to paragraph 4, where the manufacturer is not established in any Member State, and has not complied with the obligations laid down in Article 8 [QMS, PMS, vigilance, etc], the authorised representative shall be legally liable for defective devices”.

The question here is how this relates to the liability of the importer under the product liability directive, e.g. whether AR and importer are jointly and/or severally liable or may be each sued and how these actions would relate to each other. This provision has not been well thought out from a product liability perspective and will lead to problems in the future with the importer and the AR trying to pass the hot potato of liability to each other. In addition, the potential liability of the AR is not limited to product liability only (“legally liable” is a very imprecise term) which means that it may also be possible under member states’ national law to sue the AR for negligence. Furthermore, it’s a principle of liability that you cannot be liable for what you have not done or cannot control. The result of this clause will be that ARs will become very risk averse and will terminate contracts immediately upon the slightest concern, leading to situations where manufacturers will see themselves faced with the necessity of involuntary change a lot.

The MAID regulation regime now also includes obligation to inform authorities of suspicion of falsified medical devices, duty to cooperate with other links in the chain, distributors may sample to determine if devices are labeled correctly. This is a good thing, given the duty to check compliance in the previous link in the chain that was already in the Commission proposal.

News that we already knew about qualified persons: they do not need to be employed but just need to be permanently and continuously at the organisation’s disposal.

One of the big political issues: single use devices reprocessing (article 15). The Council proposes that this may only take place where permitted by national law and under certain additional EU conditions (common specifications for example), with exemption under conditions for single-use devices that are reprocessed and used within a health institution, with the option for each member state to determine if that includes devices reprocessed by third party at the request of a health institution. There will be a Commission list of single use devices that cannot be reprocessed safely and may not be reprocessed.

Amended information for patients on implants – there will not be an implant card anymore, but layman’s summary that may also be provided online.

Chapter III Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European databank on medical devices

Distributors and importers shall co-operate with the manufacturer or authorized representative to achieve an appropriate level of care professionals and health institutions to store and keep, traceability of devices (article 20).

The Commission will make a medical devices nomenclature available free of charge for interaction with Eudamed (article 23a).

More detail is provided on UDI technicalities, procedure and use; there is an obligation on the Commission to ensure that UDI stays compatible with other UDI systems.

More detailed requirements are put in place for the summary of safety and clinical performance for class III and implantable devices (article 26)

Some rules to deal with the inevitable reality of member states having put their own systems in place in the mean time: “In the design of Eudamed the Commission shall give due consideration to the compatibility of national databases and national web-interfaces to allow for import and export of data.” The Commission will also run a Eudamed helpdesk.

Until the Commission has designated the UDI assigning entities, GS1 AISBL, HIBCC and ICCBBA shall be considered as designated UDI assigning entities (article 94 (9)).

Chapter IV Notified Bodies

MDCG will play a role in the designation and assessment of notified bodies for medical devices (Commission was already involved).

There is a lot of additional detail on the designation procedure and in monitoring and assessment by and of the national designation bodies, e.g. national authorities must apply annual assessment plan approved by Commission and MDCG.

Transitional regime for notified bodies ceasing activity: “Where a notified body decides to cease its conformity assessment activities it shall inform the national authority responsible for notified bodies and the manufacturers concerned as soon as possible and in case of a planned cessation one year before ceasing its activities. The certificates may remain valid for a temporary period of nine months after cessation of activities on condition that another notified body has confirmed in writing that it will assume responsibilities for these products. The new notified body shall complete a full assessment of the devices affected by the end of that time period before issuing new certificates for those devices.” and improved regime for consequences for certificates in case of suspension of designation.

Chapter V Classification and conformity assessment 

The new and improved scrutiny system that had to happen politically will look like this, if it’s up to the Council (remember that the trilogue still has to start):

  • For implantable devices classified as class III, the notified body shall follow the procedure regarding clinical evaluation consultation as specified in section 6.0 of Chapter II of annex VIII or Section 6 of Annex IX, as applicable.
  • BUT This procedure is not required where
    • (a) the device has been designed by modifications of a device already marketed by the same manufacturer for the same intended purpose if the modifications have been demonstrated by the manufacturer and accepted by the notified body as not adversely affecting significantly the benefit/risk ratio; or
    • (b) the principles of the clinical evaluation of the device type or category have been addressed in a common specification referred to in Article 7 and the notified body confirms that the clinical evaluation of the manufacturer for this device is in compliance with the relevant common specification for clinical evaluation of that kind of device.
    • There’s not a lot more we can say about “the procedure regarding clinical evaluation consultation” as the Annexes have not been disclosed so far, so this is somewhat of a cliffhanger for the moment. From article 44 it is clear that an expert panel will be involved, likely under the auspices of the MDCG.

Specifically for the 3D print market (depending of course if 3D printing is still considered making custom made devices under the new definition that includes an industrial production process and mass production) there is an interesting QMS related provision for printed implants: “Manufacturers of class III custom-made implantable devices shall be subject to the conformity assessment procedure based on quality management system assurance as specified in Annex VIII, except for its Chapter II with assessment of the technical documentation.” (article 42 (7))

Notified bodies may impose restrictions to the intended purpose of a device to certain numbers or groups of patients or require manufacturers to undertake specific post-market clinical follow-up studies pursuant to Part B of Annex XIII. (article 45 (2a)

Improvement of certificate of free sale provision: the authorised representative can now also request it, which is helpful because in the Commission proposal these certificates could only be requested by manufacturers established in a member state (article 48), which is kind of discriminatory.

Chapter VI Clinical evaluation and clinical investigations

Amendments on clinical evaluation and possibility for class III devices to consult expert panel for clinical development strategy and proposals for clinical investigation(s) (article 49).

Exemption from clinical investigation for implantable and class III devices that are iterations of existing medical devices, under condition of PMCF and post market studies (article 49 (2a)).

Ethics Committee review for clinical investigation becomes mandatory (article 50 (3)).

New conditions for clinical trials:

  • (a) the clinical investigation was subject to an authorisation by a Member State(s) concerned, in accordance with this Regulation, unless otherwise stated,
  • (b) an independent Ethics Committee, set up according to national law, has issued an opinion on the planned clinical investigation which is not negative and which, in accordance with the law of the Member State Concerned, is valid for that entire Member State;
  • (c) the sponsor, or its legally designated representative or a contact person pursuant to paragraph 2, is established in the Union;
  • (cb) vulnerable populations and subjects are appropriately protected according to relevant national provisions;
  • (d) the foreseeable risks and inconveniences to the subject are medically justifiable when weighed against the device’s potential relevance for the subjects and/or medicine;
  • (e) the subject or, where the subject is not able to give informed consent, his or her legally designated representative has given informed consent in accordance with Article 29 of Regulation (EU) No 536/2014;
  • (h) the rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning him or her in accordance with Directive 95/46/EC are safeguarded;
  • (l) the investigational device(s) in question conform(s) to the applicable general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the subjects. This includes, where appropriate, technical and biological safety testing and pre-clinical evaluation, as well as provisions in the field of occupational safety and accident prevention, taking into consideration the state of the art.
  • (m) requirements of Annex XIV are fulfilled.

There will be a system for compensate for damage resulting from clinical trials, but the details will be entirely up to each member state’s discretion (article 50d), so we will not have any significant harmonization there.

The Council proposes a lot of additional detail on evaluation and conduct of clinical trial (article 51).

Chapter VII Post-market surveillance, vigilance and market surveillance

The proposal now contains new and very prescriptive rules for PMS system and plan as well as PSUR in articles 60a, 60b and 60c.

There are considerable adaptations to trend reporting details in article 61a.

There will be a European Market Surveillance Plan, for which The competent authorities shall draw up annual surveillance activities plans and allocate a sufficient number of competent human and material resources needed to carry out those activities taking into account the European market surveillance program developed by the MDCG according to Article 80 and local circumstances.

Chapter VIII Cooperation between Member States, MDCG, EU Reference Labs and Device Registers

The MDCG is tasked with development and maintenance of a framework for a European market surveillance program with the objective of efficiency and harmonisation of market surveillance in the European Union (article 80 (d)).

The regulation establishes expert panels and expert labs (for among other things scrutiny) (article 81a).

Chapter IX Confidentiality, data protection, funding, penalties

No interesting changes here.

Chapter X Final provisions

Many changes in the exercise of the delegation to the Commission, and limitation in time to five years with obligation to evaluate.

Minor changes in the transitional regime with respect to UD (article 97)I:

“For implantable devices and Class III devices Article 24(4) [UDI Carrier affixing] shall apply one year after the date of application of this regulation. For Class IIa and Class IIb devices Article 24(4) shall apply three years after the date of application of this regulation. For Class I devices Article 24(4) shall apply five years after the date of application of this regulation.”

For reusable devices that shall bear the UDI Carrier on the device itself, Article 24(4) shall apply two years after the date applicable for its class of devices as stipulated [in the above point].

First impression

The Council has clearly gone for an approach that does not wildly depart from the Commission’s proposal, like the Parliament chose to do. Yet, as was to be expected, the Council has tried to avoid giving the Commission too much additional power in the field of medical devices by tweaks in the delegation for the many delegated and implementing acts that the regulation empowers the Commission to take.

It is also clear that the Council has taken the criticism regarding notified body changes and exits to heart, making the changes more workable from manufacturers’ perspective and limiting the chances that they see themselves stuck with invalid certificates because a new notified body cannot phase the manufacturer in quickly enough.

However, without the Annexes there is still a lot we do not know, for example how the scrutiny regime plays out exactly in the view of the Council.

It looks like the ARs will get a truly raw deal under this new regulation and will need to seriously consider their insurance cover and terms with the new and quite unclear liability coming their way under article 9 (4a). I don’t expect the Parliament to help them, but the Commission could perhaps work on this from a consistency and coherence perspective.

Will a partial general approach be achieved? We can only guess for the moment but things are looking bright thanks to the Latvian Presidency. If it happens, the trilogue can start with the Parliament and the Commission. With a new rapporteur on the medical devices regulation dossier for the ENVI Committee it seems that the wings are no longer on fire and things may even progress quickly (for EU law making standards) – see my previous post for a timeline.


Get every new post delivered to your Inbox.

Join 4,360 other followers

%d bloggers like this: