• New Medical Devices Regulations in the EU: Significant Changes but No Big Bang
  • October 2, 2012 | Authors: Peter W.L. Bogaert; Grant H. Castle; Genevieve Michaux
  • Law Firms: Covington & Burling LLP - Brussels Office ; Covington & Burling LLP - London Office ; Covington & Burling LLP - Brussels Office
  • Today the European Commission published 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 vitro diagnostic medical devices (IVD) 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.