According to Brussels, the current regulatory regime – which has been in place for more than 20 years– is not keeping pace with recent medical developments.
Commented Michael Gavey, an intellectual property and regulator partner at international law firm Simmons & Simmons: ‘There has been heightened public awareness recently of safety issues due to the silicone breast implant scandal and problems with metal on metal hip replacements, which has undoubtedly damaged confidence in the industry,’ Mr Gavey explains.

Implants

Several changes are proposed: the extension of regulations over implants for aesthetic purposes, more stringent supervision of independent assessment bodies by national regulators, and better traceability of devices through the supply chain in the case of a recall.
However, the regime must continue to encourage innovation in the medical device industry, said Mr Gavey, especially given that fresh regulations and extra costs will be shouldered by manufacturers and distributors. ‘Industry associations have already raised concerns over the proposed scrutiny procedures and the costs of traceability requirements,’ says Mr Gavey.