Europe Legislates More Formal Notified Body Processes and Timelines Related to Recertification Part 3

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 the regulatory update series discusses Article 1 quotations, and Articles 2 and 3 on timelines and interruptions, respectively, related to new conformity assessment procedures. Part 2 is about changes to the QMS and devices, as well as recertification of product certificates (Article 5). 

This last regulatory update in the series describes Article 4 monitoring and the provisions for recertification (Articles 5-7) and, when this all becomes applicable. Note: recertification of Product Certificates was discussed in Part 2. 

Article 4 requires notified bodies to monitor time and cost

The notified body within its QMS must monitor the duration of conformity assessment activities as well as the sum of the costs. Notified bodies are expected to track the percentage of conformity assessment activities completed within the maximum timelines (Article 4(2)(a)(i)) as well as the median duration of time (Article 4(2)(a)(ii)). For costs, the median total cost of completed conformity assessments (Article 4(2)(b)). In addition, assessment of changes must be tracked. 

Article 6 Recertification for QMS Certificates

Recertification of QMS Certificates (Article 6(1)) requires the notified body to have conducted audits at least once, performed surveillance activities (on-site audits of manufacturer, subcontractors, suppliers), product tests, and technical documentation assessments on a sampling basis. If additional information is required, similar to recertification of product certificates (Article 5(5)), the additional information is limited to specific information necessary to complete the assessment (Article 6(2)).

Similar to recertification of the device, the notified body has 90 days to complete its review (Article 6(1)). And, in both cases, three interruptions are possible (Article 3(1)(e)).

Article 7 Decision on Recertification 

Recertification of the device and QMS is limited to the documents delineated in the legislation, as applicable (Article 7(1)). The notified bodies have 20 days to make the decision and reissue the certificates. Recertification reviews of the device and QMS, as prescribed by the legislation, apply only to certificates that expire after November 25, 2027 (Article 8(3)). 

Concluding remarks

Manufacturers and industry welcome the legislation as it aligns notified bodies and fosters greater transparency, efficiency and consistency. It will be interesting to monitor the duration of the conformity assessment activities, costs and the number of interruptions.