The clock started ticking today on tighter new regulations for the medical device and in vitro diagnostic industries in Europe when the European Commission published the new rules.
The regulations, approved last month by the European Parliament, include stronger post-market surveillance rules and adding a safety check for high-risk devices. The new EU rules, which also mandate a unique identification system and implant cards for patients, are slated to go into effect 3 years from today for medical devices and 5 years for IVD products.
The updated EU regulations also provide for random plant inspections after devices hit the market, stricter controls on notified bodies, an additional safety check for high-risk devices by expert panels, an implant card so patients can track which product was implanted and clinical evidence of medical device safety.
“The medical technology industry welcomes the fact that the transition and implementation period has finally come,” MedTech Europe CEO Serge Bernasconi said in prepared remarks. “Now we open a new chapter – the industry is ready to collaborate with all actors to ensure a timely and smooth transition to the new Regulations.
“MedTech Europe is fully aware that within such large and complex texts there are still a lot of questions waiting to be answered. We will continue our work with members, regulators and external stakeholders to ensure effective implementation of these new rules,” Bernasconi said.