Europe split on approvals

29 March 2013

In March the European Commission and Parliament were reported to be in a disagreement over the possible introduction of central agency to oversee the approval of medical devices. Under the proposal tabled by the Commission, the national network of regulatory agencies, currently tasked with approving the use of devices on a country-by-country basis, would retain the powers to approve but would also be able to scrutinise the work of other countries in approving products.

The Commission's proposal was in response to the Poly Implant Prothèse scandal of last year. However, German MEP Dagmar Roth-Behrendt said that in the interest of greater patient safety she would be proposing a centralised approach to the European Parliament. The proposal was discussed during a Parliament workshop. But her proposal was questioned by the European Commission's health and consumer directorate, Paola Testori Coggi, who said: "Let's not make the rules more strict where there isn't a need."



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