Brussels, 24/09/2013 (Agence Europe) - To improve the safety of medical devices the European Commission adopted two measures on Tuesday 24 September - a regulation and a recommendation - which should reassure consumers. The implementation regulation adopted by the Commission clarifies the criteria to be met by notified bodies responsible for inspecting manufacturers of medical devices. The recommendation, by design non-binding, clarifies 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. With these, the Commission hopes to restore the confidence of patients following, for example, the Poly Implant Prothèse (PIP) breast implants scandal.
Among the other tougher requirements laid down are: - a member state may only designate a notified body after a “joint assessment” conducted with experts from the Commission and other member states and the assessment reports are to be made available to all other member states; - member states are required to carry out surveillance and monitoring of the notified bodies at certain intervals to ensure that they continuously meet the requirements; if they do not, the member state must withdraw the designation as notified body; - knowledge and experience requirements of the staff of the notified bodies to be required by member states are clarified; - notified bodies must randomly perform unannounced factory audits and, in this context, check adequate production samples; failure to carry out random checks will result in the suspension or the withdrawal of the designation of the notified body; - where risks might be caused by the substitution or adulteration of raw-materials, such as in the PIP-case, a notified body must also check that the quantity of finished products corresponds to the quantity of the crucial raw material purchased.
“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” said Consumer Policy Commissioner Neven Mimica. “I am committed to support the Parliament and the Council with a view to completing the on-going revision by early next year”, he added.
These measures were announced in the Joint Plan for immediate action 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 and also improved transparency and communication between member states, industry, health professionals and notified bodies. The Commission will provide a progress report 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. Eleven such audits have taken place and eight more are planned before the end of the year. (AN/transl.fl)