European
Compliance Platform
European
Compliance Platform
What It Means for Medical Device Manufacturers
Commission Implementing Regulation (EU) 2026/977 sets uniform procedural requirements for Notified Bodies under MDR and IVDR. It specifies minimum quotation content, maximum timelines for defined assessment stages, permitted interruptions, annual monitoring and reporting, and targeted re-certification reviews.
Key fact: Expiry of a maximum timeline under IR 2026/977 is not sufficient grounds for a Notified Body to refuse to issue a certificate. The timeline caps are enforceable obligations on the NB, not manufacturer deadlines.
Primary source: official text of Commission Implementing Regulation (EU) 2026/977 on EUR-Lex.
| Aspect | Before 2026/977 | After 2026/977 |
|---|---|---|
| NB quotation content | Unstructured — NBs issued whatever level of detail they chose | Minimum content is mandatory: estimated costs and breakdown, typical surveillance/audit costs, potential extras and estimated timelines |
| Fee increase notification | No obligation — manufacturers discovered increases at invoicing | Increases >10% require advance written notice with justification before charging |
| Structured dialogue | Practices differed between NBs | NB procedures must cover exchanges relevant to issuing the quotation; the regulation does not create a general free-consulting right |
| Maximum assessment timeline | No uniform maximum periods in these implementing rules | Complete application/contract: 30 days · QMS audit: 120 · Product verification: 90 · Decision/certification: 20 |
| Clock-stop interruptions | No harmonised interruption framework in these implementing rules | Defined numbers of interruptions, with extra cases and written, justified extensions under Article 3 |
| Recertification info | Full re-submission often required regardless of changes | For quotation information on changes or re-certification, specified unchanged data need not be requested again when the manufacturer confirms no change |
| Public performance data | None — no basis to compare NB speed or cost | Annual reports with median costs and completion rates published by 30 April each year (from 2028) |
Before issuing a quotation, the NB must receive the information listed in Article 1(1), including manufacturer and SME details, relevant sites and suppliers, the device and risk class, and the requested conformity-assessment procedure. Structured dialogue must cover matters relevant to issuing that quotation. The quotation must include at least: (1) estimated overall costs, detailed for QMS and technical-documentation assessment where applicable, including typical surveillance and unannounced-audit costs; (2) estimated potential extras, using hourly fees only when duration cannot be predetermined; and (3) estimated timelines. An increase above 10% must be explained in advance. The regulation does not prescribe a single quotation template or say that broader pre-application consulting must be free.
Sets maximum periods with distinct starting points: 30 days from receipt of a complete application to contract signature; 120 days from the NB's first audit-programme activity through final QMS review; 90 days from the start of technical-documentation assessment through final product review; and 20 days after the last relevant final review for decision, certificate issue and EUDAMED entry. Planned-change review is 30 days, any additional assessment 90 days, and a needed certificate supplement 20 days. Under Annex IX, QMS and product activities run in parallel subject to the technical-documentation input needed for the audit programme. Unless otherwise agreed, the 120- and 90-day activities start the day after contract signature.
Article 3 permits interruptions for non-compliances or duly justified questions necessary for the assessment: one for complete-application review, four for QMS audit, four for product verification, five in total for planned-change phases, three for re-certification reviews, and one for certificate-information verification. Rolling technical-documentation review may include agreed additional interruptions, and each additional on-site QMS location permits two more QMS interruptions. The NB and manufacturer agree the duration and the NB confirms it in writing. EMA, authority, expert-panel or EU reference-laboratory dependencies are additional. An interruption may be extended only when duly justified and agreed in writing, so these are not absolute calendar-time caps.
NBs must monitor the percentage of activities completed within Article 2 timelines, median duration from application to certification, and median total cost in euros for the covered activities. By 30 April each year they must publish a report for activities completed in the previous year and inform the responsible authority and the Commission. Article 4(4), the annual-report duty, applies from 1 January 2028; therefore the first statutory reporting deadline is 30 April 2028.
Defines targeted documentation for product certificate re-certification, including changes since the previous certification, the latest PSUR, FSCA summary, risk and state-of-the-art changes, and the latest clinical or performance evaluation. QMS re-certification checks audit coverage, surveillance results and previous non-compliances. Product and QMS reviews have 90-day maximum periods, followed by up to 20 days for the decision and certificate re-issue. Articles 5–7 apply to reviews of certificates expiring on or after 25 November 2027.
Commission Implementing Regulation (EU) 2026/977, published 5 May 2026, specifies minimum quotation content, maximum timelines for defined conformity-assessment stages, interruption rules, monitoring and reporting, and targeted re-certification requirements for Notified Bodies under MDR and IVDR.
Article 8 is procedure-specific: Articles 1–3 do not apply where the NB and manufacturer signed a written agreement for the conformity-assessment procedure before 25 February 2027. Article 4 and Articles 5–7 have separate transitional triggers, so the relevant agreement and certificate-expiry dates must be checked individually.
Article 2 sets 30 days from a complete application to contract signature, 120 days from the first audit-programme activity through final QMS review, 90 days from the start of technical-documentation assessment through final product review, and 20 days after the last relevant final review for decision and certification. Article 3 permits defined interruptions, including written extensions when duly justified and agreed.
Yes. It applies to Notified Bodies designated under MDR 2017/745 and IVDR 2017/746. The detailed provisions apply according to the relevant conformity-assessment route and the transitional dates in Articles 8 and 9.
The quotation provides a clearer estimate for that manufacturer's scope, while annual Article 4 reports provide the percentage completed within the maximum timelines, median application-to-certification duration and median total cost for covered activities. These indicators improve comparison but do not make different device scopes fully like-for-like.
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