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.

Towards a general approach for the EU medical devices and IVD regulation proposals?

380px-EU_Consilium_Logo.svgTo get unstuck or not to get unstuck, that is the question that hangs over the medical devices regulation dossier in the Council currently.

EPSCO council 18/19 June

With the Latvian presidency drawing to an end and the EPSCO council of 18/19 June in sight, the question is whether the Council will manage to come to an agreement that enables the text of the medical devices and IVD regulations to progress to the stage of trilogue.

As I have blogged, the negotiations in the Council concerning this dossier have been all over the place, down into painstaking detail and sensitive.


With the next EPSCO council meeting  very close, the Latvian Presidency is making a last push now to make progress, as the preceding Presidencies also tried in the EPSCO councils that were always planned towards the end of the Presidency. As they say, under pressure everything become fluid and that is noticeable on the outside. Fluids, if not properly channeled, tend to go everywhere.

In an attempt to reach compromise in the points that member states still differ considerably the horse trading has started, which is never a good sign for the quality of legislation. In EU lawmaking this invariably leads to compromise texts that are drafted in a way that each party can claim that the text mean what that party thinks or texts that trade extreme positions for each other so each party can claim that they scored on their politically important issue. As we have seen in the initial public council debate, reprocessing of single use medical devices is a typical candidate for this kind of compromise.

General approach

From what I understand from my sources the current idea is to try to achieve a general approach in the Council at the 18/19 June EPSCO meeting and there is optimism that this may actually be achieved. Kudos to the Latvians if they manage the wheelbarrow of frogs across the finish!

A general approach is an agreement on headlines that allows the Council to finally progress into negotiations with the Commission and Parliament with a view to achieving a final text for the regulations. As reported earlier, the Parliament put its cards on the table in April 2014 and reported ready for trilogue right after the 2014 elections. The Commission has issued its view on the Parliament’s proposed amendments in June 2014.

The trilogue will then likely run through the Luxemburg Presidency in the second half of 2015 with the final texts being agreed during the Dutch presidency in the first half of 2016. The texts would likely be agreed during the last EPSCO meeting towards the end of the presidency, so publication of the final texts could take place after the summer in 2016 and the three years transitional period would start for medical devices (still unclear if it will be three or five years for IVDs).


table flip


But there are also different signals. I also hear that there is still the backup option to just abandon the whole project and start from scratch with regulation proposals that fit the current political climate better, although this was never on the table formally and does not seem to be on the table anymore given the optimism about the actual possibility of a general approach this presidency.

Although a reset would cost a lot of precious time, there are still some things that could be taken on board in a new project.


Remember that the 2012 Commission proposal was intended as an incremental update to the existing directives that had to suddenly account for the jump in political awareness regarding safety of medical devices following the PIP case. Speaking of which – the German courts have recently referred preliminary questions to the European Court of Justice about the degree of diligence required of notified bodies under the medical devices directive – the outcome of this case may well affect EU regulation of notified bodies. This could be accounted for in new legislation.

Also, the TTIP negotiations are still (sort of) progressing. While the EU has quite firmly stated that TTIP will not impact the medical devices and IVD regulation in the works that seems quite inevitable to as that would defeat the purpose of including medical devices in the TTIP scope. My expectation is that the TTIP results (if any) will find their way in through the many delegated and implementing acts foreseen under the medical devices and IVD regulations.

A reset may also be beneficial with regard to future proofing of EU medical devices regulation. As I have blogged, the current proposals are modeled on ‘medical device as widget’ thinking under the EU goods package. Consequently, they are not very well suited to regulate devices evolving into ‘devices as service’ and lack any significant thinking on modern software design requirements and cybersecurity. The Commission has now planned to partially remedy this (and the interface with data protection regulation (another of these important dossiers stuck in the Council)) by means of an EC Code of Conduct on Mobile Health Apps. That could should be finished in the 2nd quarter of 2016. If the regulations pass now, they will require considerable work on the fly for future proofing.


If (if) the general approach is reached on 18/19 June, the expectation is that the trilogue will likely still take considerable time because of the rather extreme nature of the many of the Parliament’s proposals and of course how much the rapporteurs for the medical devices and IVD regulation feel committed to some of the politically showy but not evidence based, not even constitutional (e.g. genetic testing proposal under the IVD regulation) or outright unworkable amendments (e.g. redefinition of medical device as anything with an ‘indirect medical purpose’) proposed. From what I have heard the rapporteurs have become more realistic, meaning that the Parliament is likely to take a more flexible approach than it looked to take initially.

The fun begins in earnest then because the Luxemburg Presidency will have the Herculean task of aligning 360 pages of proposed medical devices regulation, 360 pages of proposed IVD regulation, and the ~ 300 amendments proposed by the Parliament. This will be an interesting puzzle. Also a lot can still change and move in this process because the Parliament’s position has to be reconciled with the Council’s general approach and the Commission’s position has it has evolved since the initial proposal in 2012.


With the Council currently a black box with proposals ricocheting around in it and horse trading going on people are optimistic that a general approach can be reached on 19 June. Let’s hope for the best – it’s way past time that this dossier progresses because pending these legislative procedures most work on modernizing guidance documents has been suspended. Industry is confused because the proposals go all over the place and it’s not possible to plan for the very considerable efforts needed to phase existing devices into the new system (the EU will not allow grandfathering). This hurts the EU’s medical devices industry and EU medical devices law is starting to lag behind internationally, eroding competitiveness.

Where is the EU medical devices regulations revision? It’s complicated…

380px-EU_Consilium_Logo.svgMany people ask me these days “Hey Erik, what is the status of the revision? When will this thing finally complete?”.

Well, that’s an interesting question I often ask myself too. Of course I have my crystal ball and some bits of information from here and there but that still allows me to speculate only.

So I decided to request access to the latest documentation on the Council negotiations on the revision on the basis of EU freedom of information legislation. The Council had just published references to a bunch of documents that seemed to reflect the latest state of play.


I had already heard from sources close to the negotiations that they are pretty much stuck at the moment and the process is very slow going with many entrenched positions. Don’t forget, in 2014 the Council working group combed through each of the chapters of the medical devices regulation alone twice in about 20 meetings in total. That’s a lot of time and effort to not even get close to where you would like to be and achieve compromises that do not seem to happen.

All that seems to be completely confirmed by the rejection of my request for disclosure below. As you can see, even a rejection can provide a lot of information:

Schermafbeelding 2015-04-30 om 21.16.48

Schermafbeelding 2015-04-30 om 21.17.01

In other words, the process is so delicate at the moment that the member states do not want their positions in public. That leaves me with the impression that the process is currently like hedgehogs making love: very slow and very careful with a ‘great political will to make it work’ in the end.

The latest documents of the April meetings are not publicly accessible either. I could request those too but I already know the answer to that request I think.

I like the consolation though that the acts will be published when they are final – thank goodness for democracy and for deadpan bureaucratic statements.

So what are the member states stuck on?

Well, we had something of an idea by end of last year. In the presentations of the MHRA and BSI at the DIA Euromeeting in Paris beginning of April there was a good rundown of key outstanding issues:

  • ingested products – should they automatically be in the highest risk class (as currently proposed)?
  • ‘non-medical devices’ – what will be in Annex XV from the start; there may be a new category of so-called ‘common specifications’ (so non-technical common technical specifications) for these devices.
  • companion diagnostics – still disagreement about scope of the definition – align with FDA or not, cover selection and monitoring?
  • non-viable human tissues and cells – this will likely ‘be aligned with the ATMP regulation’, which itself is up for revision now.
  • viable biologic substances – exclusion where these support the intended purpose of the product
  • reprocessing of single use devices – member states like the Commission proposal (national prohibitions possible), but don’t agree about whether to make in-house reprocessing possible (I’m not going to those hospitals) and there is the European Parliament proposal to deal with (single use is like printing your own money, so everything is presumed reprocessible) to deal with. Remember, the trilogue still has to start and the Parliament will want to get something out of it too.
  • genetic testing – Council position to take to trilogues but there seems to be a majority that feels that the EU has no business in national practice of medicine. On the other hand, Peter Liese, the IVD Regulation rapporteur feels very strongly about this amendment regardless of how unconstitutional it is, which he sees as his baby.
  • implant card – provision of card vs provision of information
  • Eudamed & UDI – member states still disagree about what link Eudamed should have to UDI and how much detail should be left to implementing acts (over which they have little influence)
  • summary of safety and performance
  • notified bodies – supervision of notified bodies is still subject of disagreement, and should notified bodies do clinical audits?
  • pre-market approval – still one of the big ticket items, especially important to France: will we have scrutiny, scrutiny plus or a real EU devices agency like EMA?
  • clinical investigations – how do we align the clinical trials regime with the Clinical Trials Regulation with its different concepts? What clinical evidence is acceptable and how do we deal with equivalence?
  • post market surveillance – how prescriptive should the regime be and do we want regular (trend) reporting for high risk devices?
  • market surveillance & vigilance – how do we get to a coherent regime and how do we deal with risk vs incident?
  • reference laboratories – this is still being heavily debated: should there be a split between reference and testing labs? Do we even need reference labs (mainly an IVD item) for medical devices?
  • hazardous chemicals – big item for industry, member states divided over options of ban, phase out or labeling
  • classification rules – what devices get up classified (looks like implants, surgical instruments)?
  • governance and oversight – where do we get the money and the people to staff whatever it will turn out to be in the end?

This is a pretty long list of rather fundamental things to disagree about if you ask me. That is why I’m not super optimistic about a quick solution after the heroic crash and burn attempts of the Greek and Italian presidencies and the methodic current Latvian salami approach to the dossier, but hey, you never know. And it’s good to see that there is also at least some debate about the IVD Regulation. The MHRA speaker at the DIA Euromeeting compared the interplay between these issues to a game of Whack a Mole – when you think you’ve dealt with one, another pops up (again).

At least it seems there is no disagreement about the craziness of enormous scope extension of the definition of medical device proposed by the Parliament – I hope.


Time is of the essence by now – and this is the best time table we have for the moment (MHRA prediction from the DIA Euromeeting conference):

Schermafbeelding 2015-04-30 om 21.49.29

But will it blend?

But will it blend into compromises, these entrenched positions in the Council? And even then, what will the trilogue with the Commission and Parliament look like? You’ll remember that the Parliament deliberately took a completely different and far out approach on important points like hazardous substances, pre-market approval, notified bodies and genetic testing, just to mention a few. Difficult to see what the compromises on those points will look like, also because the rapporteur for the medical devices regulation dossier has changed in the mean time. I think I’ll have to boot up the crystal ball again for some more theorizing about where the institutional actors’ great political will to make it work will bring us – and when.

European Court of Justice introduces ‘product batch’ liability

logo-curiaThis blog has discussed product liability cases in relation to the EU Product Liability Directive before (for example here and here). Now there is another product liability case recently decided by the European Court of Justice, which can have big consequences for manufacturers of medical devices in the EU. This case is about pacemakers and ICDs specifically. A summary from the ECJ’s press release:

“A company which sold pacemakers and implantable cardioverter defibrillators in Germany found, after carrying out quality control checks, that those products might be defective and constitute a danger to patient health. In view of that situation, the producer recommended physicians to replace the pacemakers implanted in patients with other pacemakers provided free of charge. At the same time, the manufacturer recommended treating physicians to deactivate a switch in the defibrillators.

The insurers of the persons whose pacemaker or defibrillator has been replaced claim reimbursement of the costs relating to the replacement from the manufacturer. In proceedings between the insurers and the undertaking which markets those medical devices, the Bundesgerichtshof (Federal Court, Germany) has asked the Court of Justice whether devices that have been replaced in the case in point may be classified as defective, even though no defect has been specifically detected in those devices but the quality control checks carried out by the manufacturer on devices of the same model have disclosed a potential defect. The German court is also seeking to ascertain whether the cost of replacing those products constitutes damage for which the produce is liable under the directive.”

Let me start by saying that this case is special in the sense that the manufacturer himself recommended replacing the pacemakers of a specific type as a corrective action. The recommended corrective action for the ICDs was to deactivate a magnetic switch that might be stuck, as a result of which any cardiac dysrhythmia that could be fatal would not be recognised by the defibrillators and no life-saving shock would be given to the patient.

Not all product liability cases involve a specific corrective measure. The claim made by the healthcare insurer of the affected patients was based on product liability, which is harmonized in the EU under the Product Liability Directive. The manufacturer defended himself by arguing that although he had recommended replacing the pacemakers from a specific batch, this did not mean that they had admitted that all pacemakers in the batch were defective in the meaning of the Product Liability Directive, nor could it be assumed that every pacemaker in the recalled batch was defective just because they were in a batch that was recalled. The national court decided to refer this to the European Court of Justice for a final word on the aspects of EU law.

Product batch liability

The referring court found that the outcome of the disputes in the main proceedings depends on whether the pacemakers and the cardioverter defibrillators implanted in the insured persons concerned are defective products within the meaning of Article 6(1) of Directive 85/374. The referring court further found that it has not yet been determined whether, as those devices form part of a group of products that pose a risk of failure, they are themselves defective.

The ECJ solves this problem by introducing what seems to be a product batch liability by making the point that pacemakers and ICDs are special in that

“38 The safety which the public at large is entitled to expect, in accordance with that provision, must therefore be assessed by taking into account, inter alia, the intended purpose, the objective characteristics and properties of the product in question and the specific requirements of the group of users for whom the product is intended.

39 With regard to medical devices such as the pacemakers and implantable cardioverter defibrillators at issue in the main proceedings, it is clear that, in the light of their function and the particularly vulnerable situation of patients using such devices, the safety requirements for those devices which such patients are entitled to expect are particularly high.

40 Moreover, as observed, in essence, by the Advocate General at point 30 of his Opinion, the potential lack of safety which would give rise to liability on the part of the producer under Directive 85/374 stems, for products such as those at issue in the main proceedings, from the abnormal potential for damage which those products might cause to the person concerned.”

Because of this nature of the products and given the definition of ‘defective’ in article 6 (1) of the Directive (“A product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account […]”), the ECJ decided to interpret the scope of the concept of defect in the Product Liability Directive broadly:

“41 Accordingly, where it is found that such products belonging to the same group or forming part of the same production series have a potential defect, it is possible to classify as defective all the products in that group or series, without there being any need to show that the product in question is defective.”

The result from this broad interpretation of the concept of ‘defective’ is that the scope of the concept has been expanded to include devices in the same batch that may or may not have the defect but are subject of a corrective action to mitigate the risk that they have the defect.

This extension of the concept of defective also changes the burden of proof of the person claiming damages under article 4, one of the cornerstones of the directive since the directive is based on a trade-off between one the one hand no fault liability for the manufacturer provided that the injured person proves damage, defect and a causal link between the damage and the defect. While the producer accepts no fault liability, the “injured person shall be required to prove the damage, the defect and the causal relationship between defect and damage” pursuant to article 4.

As a consequence of this judgment, this burden of proof rule does not automatically apply in case of product liability alleged for a device in a batch of potentially defect devices subject to a corrective measure of the manufacturer. Alternatively one could assume that the burden of proof is automatically met if the manufacturer initiates a corrective action for the devices concerned, but this is not discussed in the judgment.

What damages?

The product liability directive covers two types of damages: damage caused by death or by personal injuries or damage to, or destruction of, any item of property other than the defective product itself. The second question in the judgment  was if the costs associated with the recommended explantation constituted damage caused by personal injuries. Yes, says the ECJ, because if the manufacturer itself recommends replacement to mitigate a risk, then the explantation and replacement procedure constitute such damage:

“51 In the present case, as is apparent from the order for reference in Case C‑503/13, G. recommended to surgeons that they should consider replacing the pacemakers in question.

52 In that case, the Court finds that the costs relating to the replacement of such pacemakers, including the costs of the surgical operations, constitute damage within the meaning of section (a) of the first paragraph of Article 9 of Directive 85/374, for which the producer is liable in accordance with Article 1 of that directive.

53 That finding may be different in the case of implantable cardioverter defibrillators, as G. recommended, as is apparent from the order for reference in Case C‑504/13, that the magnetic switch of those medical devices should simply be deactivated.”

Does that mean that costs for replacement of implants that you can switch off to mitigate the risk of the potential defect does not constitute damage under the Product Liability Directive (like was the case for the ICDs concerned)? Strangely enough not automatically, because

“54 In that regard, it is for the national court to determine whether, having regard to the particularly vulnerable situation of patients using an implantable cardioverter defibrillator, the deactivation of the magnetic switch is sufficient for the purpose of overcoming the defect in that product, bearing in mind the abnormal risk of damage to which it subjects the patients concerned, or whether it is necessary to replace that product in order to overcome the defect.”

In other words, we do not know very much now because this is a very factual question that each national court may decide for itself in the context of the device concerned – unlimited permutations possible.

What about devices that do not need to explanted in order to mitigate the risk resulting from the potential defect?

This case concerned the costs of the medical procedure to replace the high risk implantable medical device subject to the recall. The ECJ seems to take the view that the patient should never have to pay for the costs to remove a device that is potentially defective by the manufacturer’s own judgment and exposes the patient to very high risk if it is not removed. So, what other devices could be covered here?

First, foremost and obviously, the liability would not seem to extend to implantable devices that can diagnosed from the outside, e.g. a pacemaker that was in the batch of potentially affected products, but which can be diagnosed and established not to have the defect.

Secondly, the device has to have a particular risk profile as a consequence of which patients are in a ‘particularly vulnerable situation’ and it must have an ‘abnormal potential for damage’. What this concept means is not explained in the judgment, so this will be subject of further clarification in the courts. I will explain below why this criterion is absolutely unhelpful for medical devices (or other regulated life sciences products for that matter).

What is ‘abnormal potential for damage’?

What devices are covered by this product batch liability? The reason for product batch liability comes after all, according to the ECJ, “from the abnormal potential for damage which those products might cause to the person concerned” (point 40 of the judgment – italics added). First, it  would seem to mean that there is no reason for such liability for devices that have a lower risk profile than those devices, let’s call that a ‘normal or lower’ potential for damage. Secondly, the use of the term “abnormal” potential for damages is very tricky in my opinion because it does not take account of the fact that with all potentially dangerous products the risk is always relative to the benefits. Indeed, this is the very basis for granting market access to such devices. Viewing risk in absolute terms does not lead to a meaningful outcome because in that case pacemakers and ICDs would never be admitted to the market as a result of their ‘abnormal’ potential for damage. The ECJ seems to forget that this ‘abnormal’ risk is cancelled out by their equally abnormal benefit (you don’t die on the spot when otherwise you would).

So as a consequence of the judgment of the ECJ we now have a known unknown category of devices with an abnormal potential for damage – but what type of devices fall in that category? Indulge me in a though experiment with some basic thinking about risk management and try to point out in the below very well known GHTF risk chart  for interpreting risk and communicating about risk where you would place an ‘abnormal potential for damage’. Top right corner only (most extreme risk)? Red only (high risk)? Maybe yellow in S-5 (remote probability but catastrophic harm)?

GHTF/SG3/N15R8 Example of a Risk Chart for Communicating Internal Risk Management Activities

GHTF/SG3/N15R8 Example of a Risk Chart for Communicating Internal Risk Management Activities

Or should we think in the regulatory risk classes I, IIa, IIb or III under the Medical Devices Directive? Or only devices in scope of the Active Implantable Medical Devices Directive? This problem is impossible to solve this way, because the ECJ used an absolute and undefined term to indicate a particular risk. As a result, we have an additional point of argument between patients and manufacturers: is the risk profile of a device ‘abnormal’ enough to warrant product batch liability?

In my opinion the ECJ has done nobody a favor with the term ‘abnormal potential for damage’ because it would seem to place certain (we don’t know which ones) high risk medical devices in a fictitious group of devices that should actually not be on the market or are ‘too dangerous’ or something and therefore a special type of product liability applies. This thinking is wrong and unhelpful, because it fails to take account of the fact that all medical devices admitted to the market have a risk profile that is the contrary of abnormal in their side effects and in their failure modes. Otherwise they could never ever pass the risk management requirements under the (active implantable) medical devices directive and should not be admitted to the market.

I understand that the ECJ tried to make sure that patients would not be forced to pay themselves for removal of an active implant that the manufacturer himself says should be replaced as corrective measure. However, in order to arrive at that conclusion it did not need to go into a discussion of risk in absolute terms that flies into the face of the regulatory acquis in the field of risk management. Rather, it could have found that since a defect could only be established and managed by explanting the device in the first place, the associated costs would be the risk of the manufacturer since he ordered the recall. More practical and less confusing if you ask me, because now we are stuck with having to decide if the device concerned has a risk profile that allows it to inflict abnormal damage.


The ECJ has done its best – it seems – to arrive at a solution that leads to the result that a patient should never be stuck with the medical costs associated with the replacement of a device that is subject to a manufacturer corrective action. However, its use of language about risk in absolute terms has made things a lot less clear than they were by limiting this to a category of products with ‘abnormal potential for damage’ distinguished from other products covered by the Product Liability Directive.


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