CHANGING OF THE GUARD: MEDDEV-DOCUMENTS

wachabloesung_sscp_meddev

In addition to the known clinical evaluation, the introduction of the MDR (Medical Device Regulation) obliges manufacturers of medical devices of all classes to prepare further (safety)reports. Like clinical evaluation, these are part of market surveillance after the medical device has been placed on the market. It is planned that these reports will be transmitted to and published in the EUDAMED database, where they will be accessible to both public authorities and notified bodies. We have already informed you about the PSUR (Periodic Safety Update Report) elsewhere.

In August 2019, the Medical Device Coordination Group (MDCG) published a guidance document on the Summary of Safety and Clinical Performance (SSCP): MDCG Guidance Document 2019-9. The MDCG-guidance documents replace the MEDDEV-documents of the MDD within the framework of the MDR.

Therefore we would like to inform you about the guidelines for the report on our Regulatory Affairs Blog.