Commission calls on Member States for immediate actions to implement current legislation on medical devices

Following the discovery of the fraudulent use of non medical grade silicone in breast implants manufactured by the Poly Implant Prothèse (PIP) Company in France, the Commission calls on Member States for immediate action to be taken at national level to ensure full and stringent implementation of the current legislation on medical devices.

John Dalli, the European Health and Consumer Policy Commissioner sent a letter to the EU's Health ministers asking for their full co-operation in beginning work without delay to ensure full and stringent implementation of the current legislation on medical devices, and enjoyed the occasion to outline them his proposals for a joint plan of immediate measures to be taken at national level.

Among the measures, Commissioner Dalli asks to Member States for their co-operation within the existing legal framework to tighten controls. The actions proposed include to verify the designations of notified bodies to ensure that they are designated only for the assessment of medical devices and technologies that correspond to their proven expertise and competence; to ensure that all notified bodies in the context of the conformity assessment make full use of their powers given to them under the current legislation which including the powers to conduct unannounced inspections; to reinforce market surveillance by national authorities, in particular spot checks in respect of certain types of devices; to improve the functioning of the vigilance system for medical devices for example by giving systematic access for notified bodies to reports of adverse events, encouraging healthcare professionals and empowering patients to report adverse events, and enhanced coordination in analysing reported incidents in order to pool expertise and speed up necessary corrective actions; and to support the development of tools ensuring the traceability of medical devices as well as their long-term monitoring in terms of safety and performance, such as Unique Device Identification systems and implant registers.

Within the letter, the Commissioner also announced the measures already undertaken such as that the European Commission has asked the Scientific Committee for a more in-depth investigation on the potential health impact of faulty PIP silicone breast implants based on data from investigations by Member States in order to have greater certainty regarding the health risks, and it is continuing the preparation of the revision of the Medical Devices legislation scheduled for adoption in the course of this semester, which will take account of the results of a 'stress test' that is identifying the shortcomings come to light by the PIP case.