The 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.