Brussels, 24 September 2013
Strengthening Consumer safety: Improving the safety of medical devices
Today the European Commission adopted two measures to improve the safety of medical devices fulfilling its commitment to restore patient confidence in the medical devices sector following, amongst others, the Poly Implant Prothèse (PIP) breast implants scandal. The new rules are a Commission Implementation Regulation clarifying the criteria to be met by notified bodies1, which are responsible for inspecting manufacturers of medical devices, and a Recommendation clarifying the tasks these bodies have to undertake when they perform audits and assessments in the medical devices sector, which covers some 10 000 types of products, from plasters to pacemakers.
EU Commissioner for Consumer Policy, Neven Mimica, said that "with today's measures the European Commission further strengthens the safety of medical devices. We now have a clearer basis for unannounced audits, sample testing, or joint assessments by notified bodies. Full clarity can only be achieved through amending the basic legislation. I am committed to support the Parliament and the Council with a view to completing the on-going revision by early next year."
The measures adopted today were announced in the Joint Plan for immediate action agreed between the Commission and the EU Member States. The plan focusses on the functioning of notified bodies; the surveillance by the Member States of the products on the market, EU coordinated investigations and responses to problems with specific devices as well as improved transparency and communication between Member States, industry, health professionals and notified bodies.
Most of the actions agreed upon have now been implemented or are under implementation. The overall progress will be presented in a Commission Staff Working Document to be published in October. In addition, a pilot project of joint audits of notified bodies undertaken by auditors from several Member States and the Commission was launched earlier this year. 11 such audits have taken place and 8 more are planned before the end of the year. These actions have already, before the adoption of today's measures, resulted two notified bodies been obliged to temporarily stop issuing certificates until deficiencies have been corrected.
Examples of the strengthened requirements laid down in the measures adopted today:
For further information:
Notified bodies are independent public or private third party organisations or companies designated by the Member States to carry out control of manufacturers of medium and high risk medical devices. A control made in one Member State is valid for the whole EU. There are about 80 notified bodies for medical devices in the European Union.