On May 5, 2026, the European Commission published Commission Implementing Regulation (EU) 2026/977, the first Commission implementing act to lay down uniform binding timelines, quotation-content rules and a public performance-reporting duty for Annex VII conformity assessments under the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). It enters into force on the twentieth day after publication (May 25, 2026) and applies from February 25, 2027 (Article 9).
Recital (3) names the trigger: five years of MDR and four years of IVDR application have produced "inconsistent and divergent interpretations" of Annex VII, with SMEs facing unequal treatment across notified bodies.
What binding timelines does Article 2 impose on notified bodies?
Article 2(2) sets EU-wide maximum timelines, counted from a complete application: 30 days for the application review and contract signature (point (a)), 120 days for quality management system auditing (point (b)), 90 days for product verification, that is, technical documentation review (point (c)), and 20 days for the decision and certification, ending when the certificate is issued and entered in Eudamed (point (d)). For planned substantial changes to the quality management system or device range, Article 2(3) caps the change review at 30 days, additional conformity assessment activities at 90 days, and the certificate supplement issuance at 20 days.
Article 2(2)(c) product-verification timelines run specifically for class III and class IIb implantable MDR devices and class D IVDs, with sampling-based review for other class IIb/IIa devices and class B/C IVDs, plus dedicated tracks for companion diagnostics, near-patient testing and self-testing (recital 14). Article 3 governs interruptions: each phase has a capped number of pauses, for example four for QMS auditing and four for product verification (Article 3(1)(b) and (c)), and where an opinion of the EMA, a regulatory authority, an expert panel or an EU reference laboratory is needed, the clock is interrupted without counting toward those caps (Article 3(3)).
Who has to comply, and by when?
The act binds every notified body designated under MDR Article 36(3) and IVDR Article 32(3), and through them every medical-device and IVD manufacturer placing products on the EU market. Article 8 fixes the transitional cut-offs and Article 9 the application dates:
| Provision | Application rule (Articles 8 and 9) |
|---|---|
| Articles 1, 2 and 3 (quotations, timelines, interruptions) | Apply from February 25, 2027; do not apply to procedures with a written agreement signed before that date (Article 8(1), Article 9) |
| Article 4(1)-(3) (duration and cost monitoring) | Apply to procedures with a written agreement signed after May 25, 2027 (Article 8(2)) |
| Article 4(4) (annual public reporting) | Applies from January 1, 2028; first annual report due by April 30, 2029 (Article 9, Article 4(4)) |
| Articles 5, 6 and 7 (re-certification) | Do not apply to certificates expiring before November 25, 2027 (Article 8(3)) |
Under Article 4(4), each notified body must publish its annual report on timelines and costs on its own website and inform the designating authority and the Commission, so manufacturers can compare bodies on actual delivery rather than on marketing.
What does Article 1 require on quotations and cost transparency?
Article 1(1) fixes the minimum information a notified body must collect before issuing a quotation: manufacturer identification and SME status under Commission Recommendation 2003/361/EC, site and subcontractor details, a device description with risk classification, the conformity assessment procedure applied for, and, for re-certification, the affected certificates. Article 1(2) requires a structured pre-application dialogue to make quotations usable.
Article 1(3) fixes what a quotation must contain: estimated overall costs broken down for QMS and technical-documentation assessment, including typical surveillance and unannounced-audit costs; an estimate of potential extra costs (hourly fees only where duration cannot be predetermined); and the estimated timeline. Article 1(4) adds the cost-discipline lever: the notified body must inform the manufacturer in advance of any increase above 10 percent of the estimated costs, with reasons. Article 4(2) then requires each body to monitor the median duration and median total cost of completed conformity assessments and to publish those figures annually.
What should manufacturers do before February 25, 2027?
Three actions, in order. First, re-baseline every open and planned conformity-assessment engagement against the Article 2(2) caps of 30, 120, 90 and 20 days and the Article 2(3) change-assessment caps; engagements under a written agreement signed before February 25, 2027 stay on current terms (Article 8(1)), so the renegotiation window closes on that date. Second, request a re-issued quotation meeting the Article 1(3) content requirements, including the surveillance-cycle cost breakdown, so the budget is locked before the act applies. Third, map certificates expiring on or after November 25, 2027 into the new Articles 5 to 7 re-certification track (Article 8(3)) and brief procurement on the public performance reports landing from April 30, 2029.
For multi-body portfolios, the Article 4 public reporting turns notified-body selection into a data-driven decision; a continuous per-jurisdiction monitoring feed surfaces each body's published report the day it appears, with plans for any team and AI companionship to triage the flow.
Next checkpoints: the February 25, 2027 application of the uniform rules, the May 25, 2027 cut-on for Article 4(1)-(3) monitoring on new engagements, and the first annual reports due April 30, 2029.