Regulation (EU) 2026/977: new rules for Notified Bodies on timelines, costs and procedures
On 5 May 2026, Commission Implementing Regulation (EU) 2026/977 was published, introducing a harmonised framework of quality and procedural requirements for the activities of Notified Bodies (NBs) designated under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
The aim is to reduce operational differences between Notified Bodies, strengthen consistency in conformity assessment, and increase the predictability of related timelines.
For Manufacturers, this ensures more predictable processes, superior oversight, and a reduction in procedural timelines.
1. Transparency on quotations and cost protection
Notified Bodies will no longer be allowed to issue generic quotations. To provide a quotation to the Manufacturer, they must follow documented procedures and request standardized information, such as SME status (micro, small or medium-sized enterprise), the sites covered by the conformity assessment, and a detailed description of the device, to ensure that the application is properly defined from the outset.
The quotation shall include:
- Estimated costs for the Quality Management System (QMS) assessment.
- Costs related to technical documentation review.
- Typical costs of surveillance activities and unannounced audits.
More over:
- NB shall inform the manufacturer in advance of any cost increase exceeding 10% compared to the initial estimate.
- Any such increase must be duly justified.
2. Timelines for conformity assessment
The Regulation introduces mandatory maximum time limits for the main stages of the conformity assessment.
Application review and contract signature:
- Maximum 30 days.
- The timeline starts on the day NB receives a complete application and ends with the signature of the contract.
QMS Audit:
- Maximum 120 days.
- The period runs from the start of the first audit activity to the completion of the final review.
Technical documentation assessment:
- Maximum 90 days.
- The deadline ends with the final review of the technical documentation.
Decision and issuance of the certificate:
Maximum 20 days.
The timeline runs from the day after the completion of the final review and ends with the issuance of the certificate and its registration in Eudamed.
3. Management of timeline interruptions (clock-stops)
Timeline interruptions for clarification requests or additional information from the NB will be limited in number.
The Regulation allows:
- A maximum of one interruption for the application review and contract signature phase;
- A maximum of four interruptions for the QMS audit phase;
- A maximum of four interruptions for the technical documentation assessment phase.
The aim is to reduce delays and timelines perceived as excessively long by stakeholders in the sector.
4. Certificate renewals: streamlined procedures and predictable timelines
For recertification (certificate renewal), Notified Bodies must avoid repeating assessments already carried out during the initial certification.
The review must focus in particular on changes to the device or the Quality Management System, results from post-market surveillance activities, and real-world data derived from the post-market phase. The assessment must also take into account the state of the art and the evolution of the device’s risk profile.
Renewal timelines:
- Documentation review must be completed within a maximum of 90 days from receipt of the application.
- The final decision and re-issuance of the certificate must take place within 20 days of the final review.
5. Public performance monitoring
Notified Bodies will be required to publish reports containing information on conformity assessment timelines and the alignment between quotations and actual costs applied. This reporting mechanism is intended to enhance transparency and enable manufacturers to compare the performance of different Notified Bodies.
6. Application
The Regulation will apply from 25 February 2027. However, specific transitional provisions have been established to ensure a smooth adaptation for both Notified Bodies and Manufacturers. For a comprehensive overview of the specific transitional measures and effective dates – including exceptions for existing contracts and certificate renewals – please refer to Articles 8 and 9 of the Regulation.
