Implementing Regulation (EU) 2026/977 - Uniform Requirements for Conformity Assessment and Notified Bodies
New implementing regulation establishing uniform requirements for conformity assessment and notified bodies under Annex VII of the MDR. Sets out standardized procedures for notified body designation and conformity assessment activities.
📅 Effective / published: 2026
Manufacturers and sponsors placing medical devices on the the EU market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗