Brussels, 15/06/2012 (Agence Europe) - In a resolution adopted by show of hands in plenary on 14 June, the European Parliament calls for safety checks on medical devices, including breast implants, to be stepped up in order to avoid reoccurrence of a scandal like that of the PIP breast implants. Such proposals will fuel the debate related to review of the legislation on medical devices, to be held this autumn.
MEPs state that the PIP scandal highlighted dysfunction at both European and national level, and mainly a lack of cooperation between the authorities concerned and a lack of traceability of raw materials used for medical devices. They call on the European Commission to switch to a pre-market authorisation system for certain medical devices, including breast implants. They also call for the introduction of an implant recipient's “passport” stating the implant's specific characteristics and its potentially adverse effects, in addition to a breast implant register in each member state. These national registers would be interconnected to allow information exchange when needed, for example in cases where important defects are detected in implants. Communication of personal data should, however, be subject to patients' approval. MEPs also advocate the creation of a collective redress system to help patients obtain compensation. Regarding market surveillance, they call for checks, inspections, market surveillance and information-sharing on adverse effects to be stepped up, so as to ensure improved medical device traceability and follow-up. Finally, MEPs say, a single European database should be established to bring together information about medical devices on the market, the registration of economic operations, vigilance and market surveillance, clinical investigations, bodies notified and EC certificates issued. (IL/transl.jl)