Europe Legislates More Formal Processes and Timelines Related to Notified Bodies

By Heather Crawford and Evangeline Loh

Background

Commission Implementing Regulation (EU) 2026/977 on uniform quality management and procedural requirements for conformity assessment was published (May 4).

The legislation includes 24 recitals and nine articles. Recitals provide the background to explain the basis for the changes: “inconsistent and divergent interpretations,” “predictability,” and “efficiency.”

This update describes issuing proposals, timelines and conformity assessment activities, as parts of Articles 1-3 and Article 8.

Article 1 proposals

Article 1 describes the minimum information required by a notified body before issuing a quotation (Article 1(1)(a)-(1)(j)). Recital (5) reminds Notified Bodies to collect sufficient device information to verify it is within scope of their designation.  Article 1(2) discusses structured dialogues, which is encouraged, as recalled by Recital (8), especially during the pre-application phase. 

Article 1(3) sets out the minimum information in the quotation, including requirements related to costs and fees. If there is an increase greater than 10% of the estimate, the notified body needs to inform the manufacturer in advance (Article 1(4)).

Articles 2 and 3 timelines and interruptions, respectively

Article 2(2) establishes maximum timelines for conformity assessment activities, while Article 3 discusses Interruptions of the timeline. 

Article 2(2)(a) provides 30 days for application review and signature of the contract, with one time interruption (Article 3(1)(a)).

Article 2(2)(b) allows 120 days for QMS auditing per Section 4.5.2 of Annex VII MDR/IVDR, with a maximum of four interruptions of possible (Article 3(1)(b)). According to Article 3(1, two additional interruptions are possible for each additional site to be audited on-site.

Article 2(2)(c) established 90 days for product verification in accordance with Section 4.5.3 of Annex VII MDR/IVDR, and a maximum of four interruptions (Article 3(1)(c)).

Lastly, 20 days are allotted for the decision and certification, including entry into EUDAMED (Article 2(2)(d)).

Article 3 also discusses the Rules of Interruptions

Article 3(2) states that the timeline is interrupted once the notified body informs the manufacturer. And, subsequently, resumes once the notified body receives the information from the manufacturer. 

Concluding remarks

Articles 1, 2 and 3 apply to conformity assessment procedures for signed written agreements between manufacturers and notified bodies after February 25, 2027.

Manufacturers will welcome this legislation as it provides requirements for notified bodies related to greater transparency, efficiency and consistency. It will be interesting to monitor the duration of the conformity assessment activities, less the time that lapses during the interruptions. 

Part two of the regulatory update will discuss changes, recertification and the other articles.