Commission Implementing Regulation (EU) 2026/977 introduces uniform requirements for conformity assessment activities carried out by Notified Bodies under the MDR and IVDR, aiming to make costs, timelines and recertification procedures more transparent and predictable.
The Regulation entered into force on 25 May 2026 and provides for phased application, with different application dates in 2027 and 2028.
SCF has prepared a dedicated Focus on the key changes, providing a practical overview of the requirements, timelines and conditions of application.
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