Yes. Currently, medium and high-risk devices require a conformity assessment by a Notified Body. Notified Bodies have been designated by the Member States under the MDD. Under the MDR designation procedure, Member States and the European Commission are responsible for designation. The requirements for Notified Bodies are tougher than in the past, putting additional pressure to ensure they have the technical expertise to monitor the devices/companies they service. Notified Bodies will be required to make more informed decisions to provide a high level of safety and performance of products. Again, this is part of strengthening the protections for EU patients based on prior failures.
