On April 5, 2017, the European Parliament (EP) approved a regulation on medical devices, as well as a regulation on in vitro diagnostic medical devices.
The EP’s April 5, 2017, press release states that the medical devices regulation is intended to ensure that medical devices are traceable and comply with European Union (EU) safety requirements. The medical devices regulation addresses the use of nanomaterials in medical devices. The European Commission’s April 5, 2017, fact sheet states that the critical factor in classifying devices incorporating or consisting of nanomaterials is the potential for nanomaterials to be in contact with membranes inside the body. Those devices presenting a high or medium potential for such contact will be in the highest risk class and thus be subject to the most stringent conformity assessment procedures. To allow manufacturers and authorities time to implement the regulations, the regulation on medical devices includes a three-year transition period, and the regulation on in vitro diagnostic medical devices includes a five-year transition period.
Source: Lynn L. Bergeson and Carla N. Hutton on April 11, 2017, Posted in International, Legal/Regulatory Issues