The European Commissionnew proposed Regulations on medical and in-vitro diagnostic medical devices in 2012. The rules include tighter controls on high-risk devices such as implants, requiring a pool of experts at the EU level to be consulted before placing the device on the market.he new rules will impose tighter controls on high-risk devices such as implants, requiring a pool of experts at the EU level to be consulted before placing the device on the market. Controls will also be tightened on clinical trials as well as on the bodies that can approve the marketing of medical devices. The new rules will also cover certain, previously unregulated aesthetic products (e.g. coloured contact lenses that do not correct vision). In addition, a new system for risk classification in line with international guidelines will apply to in vitro diagnostic medical devices.
he new regulations will make sure that vital information is easy to find. For instance, patients will receive an implant card with all the essential information, and a unique device identifier will be mandatory for every product so that it can be found in the new European database of medical devices (EUDAMED).
Read also a statement by CzechMed, Czech association of suppliers of medical devices (in Czech).
20th February 2019
25th January 2019