The European Union’s (EU) Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) set forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the European Union.
Increased regulatory oversight, increased clinical evidence requirements, increased requirements for IVD manufacturers, and intensified oversight from Notified Bodies are just some of the major changes to consider compared to previous EU Directives: the Medical Devices Directive Active Implantables (AIMDD), the Medical Device Directive (MDD), and the In Vitro Diagnostic Directive (IVDD). Added to this is the European database, EUDAMED, and the implementation of the UDI to provide traceability to the devices.
This increased oversight requires manufacturers to make significant changes in product development, data reporting, and quality assurance. As a result, device manufacturers can expect higher costs and longer lead times to develop new products, as well as costly new clinical monitoring and evidence generation to re-certify many existing products. The regulations are in place in all EU member states, profoundly affecting the business models of all diagnostic and medical device companies within the world’s second largest device market.
The road has already begun, and it is key to have the correct regulatory strategy for compliance with the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746.
QSG will support you in every step for having your device on the market in compliance with the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).