EU: Commission Implementing Regulation on QM and Conformity Assessment Activities of Notified Bodies
Commission Implementing Regulation (EU) 2026/977 of 4 May 2026 further specifies requirements for notified bodies under the MDR and IVDR frameworks and aims to promote a more harmonised implementation across the European Union.
Key aspects of the regulation include:
- Harmonised requirements for quality management systems used by notified bodies
- More consistent conformity assessment procedures under MDR and IVDR
- Defined timelines and transparency obligations
- Provisions related to the recertification of medical devices
- Clarifications regarding the organisation, operation, and oversight of notified bodies
The background to the regulation is the continued challenge of inconsistent interpretations and varying practices among notified bodies across Europe. The European Commission intends to improve consistency, predictability, and efficiency of conformity assessments, particularly in light of the ongoing MDR/IVDR certification bottlenecks.
The implementing regulation will take effect on 25 February 2027, except for Article 4(4), which requires notified bodies to publish an annual report on their activities, taking effect on 1 January 2028.
Source:
EUR-Lex: Commission Implementing Regulation (EU) 2026/977 of 4 May 2026
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