EMA Issues Guidance on New Device, IVD Rules
The European Medicines Agency issued final guidance on new rules for certain in vitro diagnostics and medical devices.
European Union Regulation 2017/745 and Regulation 2017/246 introduces new roles and responsibilities for both the EMA and national competent authorities pertaining to medical devices.
The new regulations will apply to any marketing authorization application for a medicinal product with an integral medical device submitted as of May 26, 2020. The EMA strongly suggest submitting the certificate or declaration of conformity or notified body opinion as part of the initial application.