European Union: EU Medical Device Rules: New Rules Are Nearly There But Not Quite

Last Updated: May 22 2014
Article by Matthew Hall

The new European Union (EU) Regulations on medical devices and in vitro diagnostic medical devices are moving steadily towards final adoption.  The European Parliament (EP) formally approved amended texts on April 2, 2014.  These are currently with the body which advises the Council of the EU (COREPER) and, if the Council, which represents the individual EU Member States, agrees with the EP's texts, then the rules will become law.  But, bearing in mind in particular the EP elections on May 22-25, 2014, what is the likely timetable and what is still to play for?

Before looking at this, a reminder of the background; the European Commission (EC) proposed the new rules back in September 2012 and, following the EP's April vote, it is now pushing the Council hard and publicly to approve the texts.  This is driven by continuing public concern in the EU as to the safety of medical devices.  The EP name-checked three recent issues in its press release announcing its vote; breast implants, hip implants, and human immunodeficiency virus (HIV) tests.

On the substance, the EP's position has not changed since its initial vote back in October 2013.  The position taken then is well known, but, learning lessons from the "breast and hip implants scandal", in terms of changes from the EC's original position, the EP in particular wants: "notified bodies" to have a permanent team of in-house experts who meet up-to-date qualification requirements; a new group of bodies to assess devices considered "high risk", for instance, devices that can be implanted in the human body; and patients wearing implants to receive an "implant card" and be registered, so that they can be alerted if any incidents are reported with a similar product.

On the in vitro diagnostic side (which has been much less controversial), the EP in particular wants further reinforcements to  patient safety for medical diagnostic devices used, for example, to perform pregnancy tests, diabetes self-tests, and HIV and DNA tests. It also wants an ethics committee to be set up and provisions to require the informed consent of patients to testing protocols and genetic counselling.

On the timing, the immediate timetable is driven by COREPER and then the Council itself.  COREPER met on May 5 and 6 and again on May 13 and will meet once again on May 22 to discuss the way forward.  The discussions are essentially technical and progress is expected to be fast, so in practice it seems likely that the EP elections will not disrupt this.

It also seems that there are likely to be no major disagreements within the Council itself.  The Greek delegation is currently running the Council (as President of the Council, up to the end of June 2014) and it is understood to be optimistic that the texts will be finalised by the end of June and in a state to be presented to the (new) EP for second reading (with the Italian delegation, as the President of the Council from July 2014, then running things from the Council side).

Looking forward, the most interesting part of the process will probably be, as is often the case, the informal tri-partite discussions at second reading (between the EC, EP and COREPER/the Council).  In particular, the Greens at the EP may continue to insist on their points (such as stricter pre-market authorization rules).  However, naturally, the new political balance after the EP elections could upset matters.  In the normal course, assuming no major problems at the (new) EP, I would expect the two sets of Regulations to be finally adopted in 2015, with a transitional period after that for the industry.

Is it too late to influence all of this?  No, but time is short.  It will be very difficult for major changes to be introduced, but reasonable claims on specific points (supported with arguments) will still be heard.  It is clear that any advocacy (targeted first at COREPER) should take place ASAP and, preferably, through representative organizations.  The process is however moving on rapidly and it would be important for the Italian Presidency and the new EP to find submissions on various points as a legacy issue and not to encounter them as new issues.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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