Europe Legislates More Formal Notified Body Processes and Timelines Part 2 Related to Changes

By Heather Crawford and Evangeline Loh

Background Implementing Regulation (EU) 2026/977

Commission Implementing Regulation (EU) 2026/977 on uniform quality management and procedural requirements for conformity assessment was published (May 4). Part 1 of this Regulatory Update series discusses Article 1 proposals, and Articles 2 and 3 on timelines and interruptions, respectively, related to new conformity assessment procedures.

This regulatory update describes the provisions related to changes in the Quality Management System (QMS) and devices, and when this all becomes applicable. 

Article 2 Timelines for Substantial Change

Article 2(3) for substantial changes is 30 days (Article 2(3)(a)) for the notified body to decide if additional conformity assessment is required or if the planned change is approved.  These are changes to the QMS or device range covered in a QMS certificate or EU quality assurance certificate and changes to an approved device covered by a technical documentation assessment certificate or an EU type examination certificate. 

If additional conformity assessment activities are required (Article 2(3)(b)), the notified body has an additional 90 days. And, 20 days to issue the supplemental certificate (Article 2(3)(c)). 

Article 3(1)(d) allows for a total of five interruptions between Article 2(3) points (a) and (b).

Article 5 Recertification for Product Certificates

Article 5(1) dictates the information manufacturers must provide at recertification: list of changes including based on state of the art and Field Safety Corrective Actions (FSCAs), summary vigilance (PSUR and FSCAs), summary of changes to the risk evaluation with impact on benefit risk ratio, and current clinical evaluation or performance evaluation report updated with clinical investigation/performance study data and PMS. Additional requirements exist for the manufacturer if the changes are based on new standards or new common specifications, including details about the new scientific findings. 

The notified bodies are granted 90 days for assessment per Article 5(4). Requests for clarification are “limited to specific information necessary to complete the assessment (Article 5(5)).

Concluding remarks

Articles 2 and 3 relate to changes and change timelines that apply to conformity assessment procedures for signed written agreements between manufacturers and notified bodies after February 25, 2027.

More structured assessments and timelines and consistency among notified bodies related to change review is welcome by industry though this will not apply to change reviews until after February 2027. Part three of this regulatory update series will discuss QMS recertification, as well as the other articles.