Strengthening Consumer safety: Improving the safety of medical devices
EU News 411/2013
Brussels, 24 September 2013
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.
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