The new timelines introduced by Commission Implementing Regulation (EU) 2026/977 have attracted considerable attention across the medical device and in vitro diagnostics sectors. More predictable notified-body assessments could help manufacturers plan resources and market access with greater confidence.
But the new rules do not apply immediately to every certification project. The Regulation’s general date of application is 25 February 2027, and its transitional provisions distinguish between procedures according to written-agreement dates and certificate expiry dates.
Before revising a certification plan, the question is therefore not simply “What are the new timelines?” It is “Which provisions apply to this particular procedure?”
What Does Regulation (EU) 2026/977 Change?
The Regulation establishes certain uniform quality-management and procedural requirements for notified bodies designated under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). It addresses quotations, assessment timelines, interruptions, monitoring and re-certification.
Its focus is how notified bodies carry out conformity assessment. It is not a replacement for the MDR or IVDR, nor does it remove manufacturers’ responsibility for demonstrating conformity with the applicable requirements.
MedTech Europe has welcomed the measure as a step towards greater predictability and transparency, while stressing the importance of consistent implementation. It also distinguishes this procedural measure from the broader revision of the MDR and IVDR.
The full text of the regulation is available on EUR-Lex: Commission Implementing Regulation (EU) 2026/977.
In Force Does Not Mean Generally Applicable Today
The Regulation was adopted on 4 May 2026 and published in the Official Journal on 5 May 2026. Article 9 provides for entry into force on the twentieth day following publication, but sets the general application date at 25 February 2027.
These are different legal milestones. As of October 2026, the Regulation is in force, but manufacturers should not assume that its new phase-specific deadlines already govern their assessments.
Even after February 2027, there is no single switch-over for every ongoing procedure. Article 8 sets out the relevant transitional rules.
Four Dates That Determine Applicability
- 25 February 2027: Quotations, Timelines and Interruptions
- Under Article 8(1), Articles 1–3 do not apply to conformity assessment procedures for which the notified body and manufacturer signed a written agreement before 25 February 2027.
- These articles cover quotation requirements, maximum assessment timelines and interruptions of those timelines. An assessment continuing after February 2027 does not automatically fall under these provisions if the agreement covering it was signed before the cut-off.
- For example, a procedure covered by an agreement signed on 20 February 2027 is excluded from Articles 1–3 under this transitional rule, even if the assessment continues later in the year. The date of the agreement matters—not simply the date on which a review activity takes place.
- 25 May 2027: Monitoring Assessment Duration and Costs
- Article 8(2) states that Article 4(1)–(3) applies to procedures covered by written agreements signed after 25 May 2027. These provisions require notified bodies to establish a system for monitoring assessment duration and costs and specify the information it must provide.
- The wording is “after”, not “on or after”. It should not be replaced with a different threshold when interpreting the rule.
- This also means the monitoring provisions have a different applicability test from Articles 1–3. A procedure covered by an agreement signed in March 2027 may fall under the new quotation, timeline and interruption rules, but not the monitoring requirements in Article 4(1)–(3). An agreement signed in June 2027 falls after both agreement-date thresholds.
- 25 November 2027: Re-certification Reviews
- Article 8(3) provides that Articles 5–7 do not apply to re-certification reviews of certificates expiring before 25 November 2027.
- Here, the relevant criterion is the certificate’s expiry date—not the date of the original agreement or the date on which the manufacturer starts preparing its renewal documentation.A certificate expiring on 24 November 2027 falls within the exclusion. One expiring on 25 November 2027 does not fall within that particular exclusion. These provisions should therefore be assessed separately from the agreement-date tests for Articles 1–4.
- 1 January 2028: Annual Reporting
- Article 9 makes Article 4(4) applicable from 1 January 2028. This provision requires notified bodies to prepare annual reports on assessment timelines and costs by 30 April each year, covering relevant activities completed during the previous year. Reports must be published on their websites, and the responsible authority and the Commission must be informed.
- This reporting obligation is distinct from the monitoring requirements in Article 4(1)–(3). The two should not be treated as if they share one application date.
Maximum Timelines Are Not a Guaranteed Certification Deadline
Where the relevant provisions apply, Article 2 establishes maximum timelines for key assessment phases:
- 30 days for application review and contract signature, starting from receipt of a complete application.
- 120 days for quality-management-system auditing, from the first audit-programme activity to completion of the final review.
- 90 days for product verification, from the start of technical-documentation assessment for each device or representative device to completion of the final review.
- 20 days for the decision and certification phase after the last relevant final review.
These are not four durations that can simply be added together to promise an end-to-end certification date. Each phase has its own starting point, and some activities must run in parallel under Annex IX procedures, subject to the required technical-documentation input.
Article 3 also allows interruptions, often called clock-stops, while manufacturers address non-compliances or justified requests for information. Separate interruptions apply where assessment depends on an external opinion, such as from an expert panel or EU reference laboratory.
The manufacturer’s response time and the relevant interruption rules therefore matter when estimating elapsed project time. A maximum assessment period is not a guarantee of a positive certification decision.
Equally, Article 2(4) states that expiry of the maximum timelines or use of the maximum number of interruptions is not sufficient reason to refuse a certificate. The assessment must still lead to a decision based on the substantive requirements.
More Focused Re-certification Still Requires Current Evidence
Articles 5–7 establish a more targeted approach to re-certification. They specify the information and reviews required and limit requests for additional documentation to what is necessary to complete the assessment.
For product certificates, the information includes device changes, relevant post-market experience, changes to the benefit–risk evaluation and developments in the State of the Art. It also includes the most recent Clinical Evaluation Report (CER) under the MDR or Performance Evaluation Report under the IVDR.
A more focused review should not be confused with permission to rely on outdated documentation. Manufacturers still need to explain how the device, its risks and its supporting evidence have evolved.
What This Means for Regulatory and Clinical Evaluation Teams
For regulatory affairs teams, the practical starting point is to map each procedure to its own written agreement and each renewal to the relevant certificate expiry date. That mapping should come before changing project schedules or communicating new deadlines internally.
For EU MDR clinical-evaluation teams, preparation also depends on well-organised, traceable evidence. Medea™ by HubMed is an AI-assisted, human-in-the-loop workspace designed to support systematic literature research, evidence appraisal, State of the Art analysis and CER documentation.
Medea™ helps structure the research-intensive phases of clinical evaluation while preserving traceability to original sources and keeping qualified experts in control. It does not determine which transitional provisions govern a project or guarantee notified-body approval or shorter assessment times.
Regulation 2026/977 offers a clearer procedural framework. Making use of it starts with understanding when each provision applies—and preparing the evidence that the applicable assessment requires.
New timelines can improve predictability. They do not replace careful applicability checks or robust clinical evidence.
Shorter timelines will not compensate for weak clinical evidence. See our analysis of the Top 5 Reasons Notified Bodies Challenge CERs Under EU MDR.
Is your clinical evidence ready for re-certification?
- Use the Medea™ CER Maintenance Calculator to estimate the time and cost of keeping your CERs current.
- Apply to join the Medea™ Early Adopter Program, now extended until 30 November 2026.
- Book a 15-minute demo to see Medea™ in action → https://www.hubmed.ch/contactus