Deadlines for the completion or mandatory use of various modules have been postponed. As a reminder, the EUDAMED database will consist of six modules for the following areas:
Registrierung von Akteuren, einmalige Produktkennung (Unique Device Identification, UDI) und Produktregistrierung, Notified bodies und Bescheinigungen, klinische Prüfungen und Leistungsstudien, Vigilanz und Marktüberwachung.
- Full functionality of all modules has been postponed from Q2 2024 to Q2 2027
- The mandatory use of the Actor, Market Surveillance, Vigilance, and Clinical Investigation/Performance Studies modules has been postponed from Q2 2024 to Q2 2027
- The mandatory use of the UDI/Medical Devices Registration and Certificates/Notified Bodies modules has been postponed from Q2 2026 to Q2 2029
If the Summary of Safety and Clinical Performance (SSCP) is not included in EUDAMED, it shall be made available to the public immediately upon request, or the manufacturer shall indicate where the report has been made available to the public. The Summary of Safety and Clinical Performance (SSCP) is one of the documents used to monitor the safety and effectiveness of medical devices already on the market and is required for implants and class III medical devices (excluding custom-made and investigational devices).
Further information and access to EUDAMED can be found here or you can contact us for help.
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