Brussels, 12/05/2016 (Agence Europe) - An agreement is beginning to take shape on the new Community regulation aimed at preventing any repetitions of the breast implant scandal. Although the inter-institutional meeting on Wednesday 11 May was inconclusive, the next meeting may indeed be so (see EUROPE 11522). Two questions are still pending: one regards retreatment and the other, genetic advice.
The proposals for the regulation seek to provide a framework for the marketing and follow-up of medical devices and in-vitro medical devices. These texts are based around 200 articles and 30 annexes (a total of 350 pages) and would govern the controls of devices after their marketing. They also outlined the scope and responsibility of the notified bodies (third-party public organisations or private companies appointed by the member states that authorise the marketing of devices with the "EC" level). It should be pointed out that the Parliament reached its position in a first reading in April 2014 and the Council, in June 2015. Since then, nine trilogues have already taken place and according to a source close to the dossier, the 10th is expected to be decisive.
Retreatment is the main stumbling block. Since the beginning of the discussions, the Parliament and Council have been discussing the way in which to frame the re-use of single use devices. This practice has been banned in France and authorised, subject to certain conditions, in Germany. Over the course of their meetings, the two institutions have managed to reach an agreement on banning re-use, in exchange for a possible derogation for member states that want to adopt specific national regulation. For these member states, manufacturers will be obliged to obtain the "EC" label, contrary to the hospitals and subcontractors (which will only have to be supervised by a notified body). The European Commission is opposed to this new provision because it could possibly lead to market fragmentation and damage the principle of fair competition between operators. Over the course of the two most recent trilogues, it put forward different proposals in an effort to reconcile the different views. The most recent was presented to the Committee of Permanent Representatives (Coreper) and seeks to ban re-treatment in subcontracting and to replace the negative list (devices banned for retreatment) by a positive list for authorised devices.
The other question still pending involves genetic advice about in vitro medical devices. Parliament wants the patient wishing to use a device for diagnosing predispositions to diseases to require obligatory advice beforehand by professional. The Council believes that this request goes too far and thinks that member states should be the only ones responsible for ensuring that patients receive "appropriate access" to this kind of advice.
The next trilogue will take place on 25 May. Stakeholders are hoping to reach an agreement on this date, which will allow for the formal adoption of the text in a second reading by the Health Council 16-17 June. Once adopted, the new rules will apply after three years for medical devices and after five years for in vitro devices. (Original version in French by Sophie Petitjean)