EC Public Health · May 05, 2026

Implementing Regulation (EU) 2026/977 – uniform requirements for conformity assessment and notified bodies (Annex VII)

Implementing Regulation (EU) 2026/977 establishes uniform requirements for conformity assessment and notified bodies under the MDR/IVDR regime.

High obligation Framework Medical Devices & IVD EU-wide Medical devicesCE markingNotified bodies

News announcement 5 May 2026 Implementing Regulation (EU) 2026/977 – uniform requirements for conformity assessment and notified bodies (Annex VII) Implementing Regulation (EU) 2026/977 – uniform requirements for conformity assessment and notified bodies (Annex VII) 1 min read

Dates and deadlines

Regulatory Deadline

May 05, 2026

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Published by EC Public Health. HealthSignal links to the original document; the summary above is extracted from the source text.