On September 26, 2012 the European Commission adopted its long awaited proposals for the revision of the EU regulatory framework for medical devices. Three Directives, i.e., Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitrodiagnostic medical devices (IVDs), will be replaced by two Regulations: one Regulation on medical devices and one Regulation on IVDs. Importantly, unlike Directives that must be implemented into national laws, the Regulations will be directly applicable in all EU Member States and so are intended to eliminate current national differences in regulation of medical devices.
Despite the fanfare, the proposed regulations do not fundamentally alter the regulatory structure for medical devices in the EU. There will still be no central EU agency with responsibility for medical devices. There will still be no pre-market authorization of medical devices by national regulatory authorities. Medical devices will still be subject to conformity assessment procedures, which for higher risk devices will involve independent third parties, known as notified bodies. Medical devices must still be CE marked prior to being placed on the market.
Over the coming weeks we will publish a series of posts analyzing specific aspects of the proposed regulations.