Brussels, 09/12/2013 (Agence Europe) - Medical devices and in vitro diagnostic medical devices will be on the agenda of the Health Council of this Tuesday 10 December. The competent ministers will hold an exchange of views on the two draft regulations, to give an indicationof the direction of travel for the Greek Presidency. The ministers will give their opinions on two points in particular: 1) how can the medical devices supervision process be improved without increasing the administrative burden? 2) under what conditions may a medical device, in particular a medical device classified by the manufacturer as “single use”, be reprocessed without hampering patient safety?
Medical devices cover a broad range of products. Similarly, there is an enormous variety of in vitro diagnostic medical devices, such as analyses of blood and other products to provide information on a person's state of health. Medical devices and in vitro diagnostic medical devices are not currently subject to any authorisation prior to going on sale, unlike medicines. They are subject to a conformity assessment which, depending on the risk potential of the product, involves an independent third party, the notified body, which is designated and monitored by the member states. This supervision mechanism showed its weaknesses when the scandal of faulty PIP breast implants, which fraudulently slipped through several nets, broke. The proposals of the European Commission, which were tabled on 26 September 2012, aim to reinforce the transparency and safety of these devices in order to prevent the recurrence of any such scandals, by improving their traceability and strengthening market surveillance as well as increasing the powers of the notified bodies. The EPadopted its position on the Commission's draft on 22 October and approved the provisions calling for tighter controls and traceability for the products. The German rapporteurs, Dagmar Roth-Behrendt (S&D) and Peter Liese (EPP), have received their mandate to negotiate with the Council once it has arrived at its own opinion, in order to reach a common position on the dossier.
The Council will also adopt conclusions on the reflection process on modern, sustainable and needs-focused health systems. (IL/transl.fl)