Brussels, 21/06/2013 (Agence Europe) - Members of the internal market and consumer protection committee of the European Parliament (IMCO) adopted by a large majority, on 18 June, two reports by Nora Berra (EPP, France), one on medical devices and the other on in vitro diagnostic medical devices. In her report on medical devices, Berra proposes an alternative solution to a centralised procedure for the marketing of high-risk products (such as breast implants). This solution is put forward by Dagmar Roth-Behrendt (S&D, Germany), who is rapporteur for the environment committee. It was decried, however, by the implant industry which fears it will cause pointless delays (see EUROPE 10842). Berro proposes to set in place a form of prior authorisation before marketing that does not take long and is limited to what is essential in its scope, and encourages manufacturers and notification bodies to work together in order to harmonise assessment practices at European level and, thus, to reduce disparities noted from one country to the other. The rapporteur also moots the idea of introducing an obligation by the manufacturer to subscribe to civil liability insurance, in order to protect patients from the risk of damage and insolvency on the part of the manufacturer. The report also contains proposals for strengthening market surveillance and vigilance. The environment committee is expected to vote on the Roth-Behrendt report during July. (IL/transl.jl)