Outlines of the medical devices Recast become more fixed with Council conclusions

Since the High Level Meeting end of March where the Commission outlined its plans for the Recast of the Medical Devices Directive and took stock of the feelings about it in the industry, the project has been moving forward in the political channel. It has to if the Commission wants to be able to present a proposal that has a chance to succeed early 2012 as currently envisaged. For a proposal to succeed in the legislative procedure it need to have the backing of the EU member states, represented in the Council.

The Council has recently discussed the results of the High Level Meeting in the 3095th Council meeting on Employment, Social Policy, Health and Consumer Affairs – Health issues and has indicated where it thinks that devices legislation in the EU should go, providing an important signal to the Commission what elements are accetable for the member states in the upcoming proposal.

The conclusions reached by the Council are very much in line with those reached by the Commission further to the High Level Meeting, showing that the member states and the Commission are roughly in line about what the proposal should be. That’s not surprising, given the amount of discussion that preceeded this at adminstrative level in Brussels.

The conclusions of the Council

The conclusions of the council give us more bearing on what the Recast will look like. Here are some of the policy aims stated that I find particularly interesting:

  • Particular attention to interoperability and safety issues related to the integration of medical devices in e-Health systems, especially Personal Health Systems and mobile health systems (m-Health) while bearing in mind that the deployment of health ICT systems is entirely a matter of national competence;
  • Encourage better consideration of the needs of patients and healthcare professionals in the design process of medical devices;
  • Considering further improving the involvement of patients and healthcare professionals in vigilance in order to improve the system of notification of adverse incidents relating to the use of medical devices;
  • Promotion of early dialogue between manufacturers, scientific and clinical experts, competent authorities and, where appropriate, notified bodies regarding “new products” in particular, and their classification;
  • Particular attention to interoperability and safety issues related to the integration of medical devices in e-Health systems, especially Personal Health Systems and mobile health systems (m-Health) while bearing in mind that the deployment of health ICT systems is entirely a matter of national competence;
  • Encouraging better consideration of the needs of patients and healthcare professionals in the design process of medical devices;
  • Consider further improving the involvement of patients and healthcare professionals in vigilance in order to improve the system of notification of adverse incidents relating to the use of medical devices;
  • Promote of early dialogue between manufacturers, scientific and clinical experts, competent authorities and, where appropriate, notified bodies regarding “new products” in particular, and their classification; and
  • Enhanced cooperation between authorities of relevant sectors.

This should result in inclusion of the following elements in the Recast proposal (again, a selection of mine of points that particularly interest me personally and professionally):

Improved risk based classification

Council conclusion: The system of risk based classification should be improved (in particular for in vitro diagnostic medical devices and “new products” as appropriate).

This is not that surprising, given the discussions that have been going on about the current classification methodology, which is not risk based at all for in vitro diagnostic devices and seen as insufficiently precise for medical devices in general.

Clinical data

Council Conclusion: Clinical data from pre-marketing studies and post-marketing experience (vigilance reports, post-marketing clinical follow-up, European registers) must be collected in a transparent way and to a greater extent in order to provide the clinical evidence which fulfils regulatory purposes and can, where appropriate, assist health technology assessment, whilst fully recognising and respecting national competences for the latter.

This signifies a much needed increase in emphasis on clinical support of the safety and efficacy of medical devices. Although incremental improvements were made with the revision under Directive 2007/47 with the increased demands regarding clinical evaluation, the Recast will likely take an additional step in this respect. In my view, this a response to the growing criticism that the EU allows devices onto the market that have too little clinical substantiation at that their time of market entry. Stricter  requirements on pre- and particularly post marketing clinical data will strengthen the fast track to the market that makes the EU system so successful by making sure that manufacturers actually do meet their PMS obligations and improve the underlying clinical material for their devices.

Notified bodies

Council Conclusion: Consideration should also be given to methods for ensuring that notified bodies are better equipped with the appropriate expertise to analyse such data in a meaningful way.

This again is a response to in some cases well-deserved criticism. Notified bodies, in my experience, are sometimes stretched too thin in the expertise that they actually employ and often need to resort to contracting out a significant amount of work to external experts. The expert’s recommendations are then only appreciated marginally so the notified body may take a certfication decision based on recommendations it may not fully understand itself or cannot explain to the manufacturer. An important step in the right direction was made by the signatories to the Code for Notified Bodies, which among other things imposes requirements on the expertise that notified bodies must have and timelines they should meet.


Council Conclusion: There is a need for clearer and simpler rules defining the obligations and responsibilities of all economic operators and the role of other stakeholders (in particular national competent authorities and notified bodies).

Although it is not completely clear what shape these rules will take, this refers to the system of post marketing surveillance that works less than perfect. in my experience member states’ competent authorities are woefully understaffed for the supervision of medical devices compared to the resources available for medicinal products supervision. Also, the legal status of acts of notified bodies is often not clear (is it an administrative act by a body with supervisory powers or is it performance under a civil law contract between two private parties?).

Information sharing / EUDAMED

Council Conclusion: The development of a modern IT infrastructure for a central and publicly available database must be further pursued with a view to providing key information about medical devices, relevant economic operators, certificates, clinical investigations and field safety corrective actions. In this context, the possibility of introducing a system to improve the traceability of devices, thus enhancing safety, must be studied.

This is a respsonse to the criticism that traceability is problematic in the medical devices sector and that information about what medical devices are approved for what purposes is difficult to find, if available at all. Indeed, traceability can be improved a lot in the devices industry and again the medicinal products industry is ahead in developments in this field. So, the expectation is that the recast will legislate in that direction. There are some initiatives underway already (like the UDI), and it will be interesting to see what place such initiatives will get in the Recast proposal. My firm educated expectation is that the EUDAMED database will be expanded for this purpose and will be partially open to the general public.

Definition / classification

Council Conclusion: Where necessary, clarification should be made regarding the definition of medical devices and the criteria for their classification. In addition, a simple and rapid mechanism must be set up for accelerated adoption of binding and consistent decisions and the implementation thereof on the determination of products as medical devices and the classification of medical devices in order to address the growing number of “borderline” cases between medical devices and other products subject to different regulatory frameworks (the framework for pharmaceuticals in particular, but also those for cosmetics, aesthetic products, food or biocides).

An important item with the developments of convergence of medical devices, medicinal products and ATMPs, with companion diagnostics and combination products as very striking examples. This item will likely be followed up along the lines of the Dutch initiatives to create an EU variant of the US office of combination products. Hopefully more work will be done on the definition of medical device with respect to software, although I expect that this will not go further than the pending work on an interpretational document on software that is currently in the works.

Notified bodies oversight

Conclusion Conclusion: As regards the oversight of notified bodies, there is a need to continue to improve the harmonised list of criteria to be satisfied before their designation. In particular the designation process should ensure that they are designated only for the assessment of devices or technologies which correspond to their proven expertise and competencies. The process should also address the need to improve monitoring of notified bodies by national authorities in order to ensure an EU-wide comparable and high-level performance of notified bodies, in this context an enhanced European coordination between competent authorities as well as between notified bodies should also be considered.

This is about the diverging difference in quality of notified bodies and doubts about whether some member states are issuing accreditation decisions based on sufficient due diligence and supervision of the notified bodies. Also here there is a big problem with the often insufficient resources and expertise that member states make available for supervison of notified bodies. the EU is now thinking about a way to create some kind of supervision mechanism of notified bodies on an EU level, and given the outcome of the High Level Meeting some options have at least been struck off of the list (like the EMA solution of locating this supervision at the EMA). The fact that the member states now support moving the supervision of notified bodies to an EU level means it will happen. What it will look like is still not clear. I don’t expect (de)accreditation by an agency at EU yet, but more someting like a procedure along the lines of the current safeguard procedue under the medical devices directive for revocation of CE marking of specific devices. Hopefully such a procedure will be quicker and more effective than that.


Council Conclusion: The vigilance system for medical devices must be further developed in order to allow a coordinated analysis and a rapid and coherent EU-wide response to safety issues, if needed.

As discussed above, vigilance must be improved and can be improved. EUDAMED is an important step in the right direction by making sure that all authorities have the same information. In addition I think the system could be made a lot more effective by developing the possiblity to nominate a coordinating authority for individual vigilance issues that play in multiple member states, as described in the Vigilance MEDDEV guidance document.

Regulatory gaps

Council Conclusion: It should be considered how to address regulatory gaps in the system, for instance in relation to medical devices manufactured utilising non-viable human cells and tissues.

This a well-known regulatory gap, and it should be addressed. Other well known gaps are for example also the purely cosmetic implants other than breast implants.

Instructions for use (e-labelling?)

Council Conclusion: The need for introducing more harmonised provisions relating to the content, presentation and comprehensibility of the instructions for use of medical devices should be further considered.

The big ticket issue here is of course the question whether e-labelling will finally be allowed and under what conditons. Important considerations will be the type of end-user may be provided an e-labelled device, what the requirement for the e-label will be and in what language(s) they will be allowed. Also, I could imagine that it would be incredibly useful to oblige manufacturer to make the most recent version of the instructions for use for available via the internet additional to the paper version.

In conclusion

The Council document provides an important outline of whatbthe Recast proposal will look like. Of course the finessess will be hashed out in the period between now and beginning 2012. Then the Parliament will have the opportunity to propose amendments and I am sure the lobbying efforts for that have started already. So, we’re not there yet, but we seem to know where approximately we are going: to a welcome opportunity to optimise a regulatory system which, although it has received merited and unmerited criticism, is and will continue to be a success compared to other systems.

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