Implementing Regulation (EU) 2026/977
- Date
- May 4, 2026
- Category
EU Regulations
- Description
1 What is new from a regulatory perspective?
The European Commission adopted a new Implementing Regulation (EU) 2026/977 in response to inconsistent and divergent interpretations by notified bodies of certain requirements laid down in Annex VII to Regulations (EU) 2017/745 and (EU) 2017/746, particularly with regard to quotations, completion timelines and re-certification. It lays down uniform quality management and procedural requirements to ensure a more harmonised and predictable application of those requirements across the EU market. While the Regulation does not introduce new substantive requirements for device safety or performance, it reinforces the procedural framework for conformity assessment, changes and re-certification. Although formally addressed to notified bodies, its practical effectiveness also depends on manufacturers providing complete, consistent and assessment-ready information at the quotation, application, change notification and re-certification stages.2 Main contents of the Regulation and what they mean for manufacturers
2.1 Standardised quotations and pre-application information
A notified body may now issue a quotation only if it has received a defined minimum set of manufacturer information. This includes for example the manufacturer’s identity, authorised representative details where applicable, site data, relevant suppliers/subcontractors involved in design or manufacturing, device description, intended purpose, specific technologies/processes, risk classification and the requested conformity assessment route [Implementing Regulation (EU) 2026/977, Article 1(1) (a) – (j)].
The quotation must contain at least the estimated overall costs, a breakdown for QMS and technical documentation assessment where relevant, typical surveillance and unannounced audit costs, estimated extra costs where applicable, and the estimated timeline(s). If actual costs are expected to exceed the estimate by more than 10%, the manufacturer must be informed in advance, and the increase must be justified. [Implementing Regulation (EU) 2026/977, Article 1(3) and Article 1(4)].
Manufacturer impact: Manufacturers should build a standard pre-application package for notified body interactions, including scope mapping, device-family overviews, site master data and outsourcing maps. This will reduce quotation delays and support better budget predictability.2.2 Maximum timelines for conformity assessments
Article 2 introduces maximum timelines for key phases of the conformity assessment process:
⦁ 30 days for application review and contract signature after receipt of a complete application.
⦁ 120 days for QMS auditing until completion of the final review.
⦁ 90 days for product / technical documentation assessment until completion of the final review.
⦁ 20 days for the decision and issuance of certificates after the last relevant final review.
Where Annex IX procedures apply, QMS auditing and product verification are expected to run in parallel, provided that the technical documentation assessment appropriately informs the audit program.
Manufacturer impact: These timelines improve project planning and launch visibility, but they do not eliminate the need for complete and internally aligned technical documentations. Manufacturers that submit fragmented or inconsistent files will still face interruptions and avoidable delays.2.3 Limited interruptions
The Regulation limits the number of interruptions that a notified body may use for different phases of the process. ONE interruption is possible for the application/contract phase, FOUR for QMS auditing, FOUR for product verification, FIVE in total for change assessments and THREE in total for re-certification reviews, with only defined exceptions for rolling review arrangements or additional audited sites [Implementing Regulation (EU) 2026/977, Article 3(1)]
The timeline is interrupted when the notified body sends its request and resumes when the requested information is received, unless otherwise agreed. Additional interruptions also apply when input is needed from EMA, a regulatory authority, an expert panel or an EU reference laboratory [Implementing Regulation (EU) 2026/977, Article 3(2) – ( 4)].
Manufacturer impact: Response packages to notified body questions should be “right first time”. RA, QM, R&D, Clinical/Performance and Risk Management teams should align on version control, evidence strategy and approval timelines before responding.2.4 Planned changes become more proceduralized
For substantial changes to the QMS or the device range covered by a certificate, and for changes to approved devices, the Regulation introduces maximum timelines of 30 days for the review of the planned change, 90 days for any additional conformity assessment activities, and 20 days for issuance of the certificate supplement where required [Implementing Regulation (EU) 2026/977, Article 2(3)].
The Regulation also clarifies that expiry of the maximum timelines or the use of the maximum number of interruptions is not in itself sufficient reason for the notified body to refuse issuing a certificate or approving a change [Implementing Regulation (EU) 2026/977, Article 2(4)].
Manufacturer impact: Manufacturers should review change-control procedures against notified body expectations, particularly for significant design changes, manufacturing process changes, supplier transfers, scope extensions and changes made to address state-of-the-art or regulatory updates.2.5 Annual transparency on notified body timing and cost performance
Notified bodies must establish a monitoring system covering the duration and costs of conformity assessment activities. By 30 April each year, they must publish a report showing at least the percentage of activities completed within the maximum timelines, the median duration from application to certification, and the median total cost for completed procedures [Implementing Regulation (EU) 2026/977, Article 4].
Manufacturer impact: Manufacturer teams will gain a more objective basis for notified body selection, escalation discussions, planning assumptions and benchmarking of service performance.2.6 Re-certification becomes more focused, but more evidence-driven
For product certificates, manufacturers must provide a structured package for re-certification, including a list of all relevant changes since initial certification or the last re-certification, the latest PSUR or equivalent PMS-related safety information, a summary of field safety corrective actions, an updated view of changes to risk evaluation affecting the benefit-risk profile, state-of-the-art driven changes and the latest clinical evaluation report or performance evaluation report. The manufacturer must also identify changes not yet notified but necessary to address new regulatory requirements, common specifications, scientific findings or standards [Implementing Regulation (EU) 2026/977, Article 5(1) – (3)].
For QMS certificates, re-certification is focused on surveillance results, the audit programme and sampling plan, the status of nonconformities and CAPA, any conditions or limitations applied to the certificate, and whether the certificate scope remains appropriate. The explicit policy intent is to avoid unnecessarily repeating initial certification in full. [Implementing Regulation (EU) 2026/977, Article 6(1)–(2)].
Manufacturer impact: Re-certification readiness now depends even more on continuous life-cycle maintenance of PMS/PSUR, CER/PER, risk management, change records and state-of-the-art monitoring.3 Dates of application
The Implementing Regulation (EU) 2026/977 enters into force on the twentieth day following publication in the Official Journal and applies from 25 February 2027.
Arts. 1 – 3 Only for conformity assessment procedures with written agreement signed on/after 25 Feb 2027
Art. 4(1) – (3) Only for conformity assessment procedures with written agreement signed after 25 May 2027
Art. 4(4) From 1 Jan 2028
Arts. 5 – 7 Only for re-certification reviews of certificates expiring on/after 25 Nov 2027
[Implementing Regulation (EU) 2026/977, Articles 8 – 9]