With the release of the new European Regulation on medical devices (EU) 2017/745 the manufacturers must expect new requirements.
The most important changes are:
- higher requirements for the technical documentation
- much higher requirements for the compilation and evaluation of clinical data concerning the clinical evaluation report
- higher requirements for reporting obligations: Post Market Surveillance Plan/Report (PMS), Post Market Clinical Follow-up Report (PMCF), Periodic Safety Update Report (PSUR), Summary of Safety and Clinical Performance (SSCP)
- introduction of an unique device identification number – UDI
- EU-wide standardisation of the test certificates issued by the notified bodies – MDR certificate
- introduction of a mechanism for scrutiny: notified bodies may report each new application for conformity assessment to an established Medical Device Coordination Group (MDCG)
- the national database EUDAMED becomes publicly available
- greater controls and unannounced audits by notified bodies in the context of the quality management system
All European Notified Bodies lose their designation by the regulatory framework and will be selected and reviewed again. Proposals for a new designation can be made soonest six months after date of entry into force of the Regulation.
All of the valid MDD certificates remain valid until they expire or up to four years after request (May or June 2024).