On 4 May 2026, the European Commission adopted Commission Implementing Regulation (EU) 2026/977, published on 5 May 2026, introducing new procedural requirements applicable to notified bodies carrying out conformity assessment activities under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR).
The Regulation aims to increase consistency, transparency and predictability in the conformity assessment process across the European Union, addressing the significant differences in practices that manufacturers have experienced among notified bodies since the application of the MDR and IVDR framework.
The new rules do not amend the substantive requirements applicable to medical devices or IVDs, but instead focus on the operational aspects of conformity assessment procedures conducted by notified bodies.
New requirements relating to quotations
One of the main areas addressed by the Regulation concerns the issuance of quotations for conformity assessment activities.
Under Article 1, notified bodies may issue quotations only after receiving a minimum set of information from the manufacturer. Quotations must include:
• estimated costs relating to quality management system (QMS) assessments and technical documentation reviews;
• estimated costs for surveillance activities and unannounced audits;
• estimated timelines for the relevant activities; and
• information regarding potential additional costs that may arise during the conformity assessment process.
In addition, notified bodies must inform manufacturers in advance where costs are expected to exceed the original estimate by more than 10%, including the reasons for such increase.
These provisions will apply to conformity assessment procedures governed by agreements signed on or after 25 February 2027.
Introduction of maximum timelines
The Regulation also introduces maximum timelines for several phases of the conformity assessment process.
Under Article 2, the following timelines are established:
• up to 30 days for application review and contract signature;
• up to 120 days for QMS audit activities;
• up to 90 days for technical documentation assessment; and
• up to 20 days for the final certification decision and issuance of certificates.
Specific timelines are also introduced for the assessment of planned substantial changes affecting certified devices or quality systems.
Article 3 regulates the possibility for notified bodies to interrupt these timelines in specific circumstances, including where manufacturers must address non-conformities or respond to justified requests for clarification. Any interruption must be agreed with the manufacturer and documented in writing.
The Regulation also clarifies that exceeding the applicable timelines does not automatically prevent the issuance of a certificate or approval of a requested change.
These provisions will apply to conformity assessment procedures governed by agreements signed on or after 25 February 2027.
Transparency obligations for notified bodies
The Regulation introduces additional monitoring and transparency obligations for notified bodies.
Starting from 2028, notified bodies will be required to publish annual reports containing information on the effective duration and costs of their conformity assessment activities. Such reports must also be made available to the relevant supervisory authorities and to the European Commission.
Re-certification procedures
The Regulation also establishes more harmonised requirements for re-certification procedures relating to both product certificates and QMS certificates.
Manufacturers applying for re-certification will be required to submit specified documentation, which must be assessed by the notified body within defined timelines. The Regulation also introduces deadlines for the final re-certification decision and re-issuance of certificates.
The new re-certification provisions will not apply to certificates expiring before 25 November 2027.
Conclusion
Commission Implementing Regulation (EU) 2026/977 introduces a more structured procedural framework for conformity assessment activities under the MDR and IVDR system. The new provisions are intended to harmonise certain operational practices among notified bodies, particularly in relation to quotations, timelines, transparency obligations and re-certification procedures.