On 5 May 2026, the Official Journal of the EU released Commission Implementing Regulation (EU) 2026/977. This Regulation lays down uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body under the EU Medical Devices Regulations (MDR and IVDR). The new rules aim at addressing diverged practices among notified bodies across the EU, increasing transparency on quotations and timelines, and streamlining re-certifications, among others.
This implementing regulation sets provisions on:
- How notified bodies issue quotations
- Length of the conformity assessment activities
- How timelines can be interrupted
- Costs and durations‘ monitoring and publications
- Re‑certification (products and QMS)
What changes: enhanced transparency and defined timelines
Before issuing a quotation, notified bodies must receive defined minimum information, including:
- Manufacturer identification + SME status data
- Authorised representative’s details (if applicable)
- All QMS sites (addresses, staff, activities)
- Key suppliers and subcontractors
- Device description, intended purpose, risk class, technologies
- Applicable conformity assessment route
- Details of planned changes or re‑certification scope
Quotations will have to include clear cost breakdown, estimated timelines, and estimates of possible additional costs.
The timelines cannot exceed the following caps:
- 30 days for application review and contract signature
- 120 days for a QMS audit
- 90 days for technical documentation and product verification
- 20 days for final decision and certificate issuance
Also for substantial changes, the regulation sets defined timelines. Where there is a need for a manufacturer to address non-compliances, or duly justified questions and requests from the notified body, the notified body may interrupt the timeline of the conformity assessment activities. Also for such cases, the regulation sets defined timelines.
Re-certification: no assessment as initial certification
The provisions related to Articles 5 to 7 of the implementing regulation are the most impactful updates. For product re-certification, notified bodies must focus only on changes since last certification, PMS and PSUR data, FSCA history, risk updates, state of the art evolution, as well as clinical and performance evaluation updates. For QMS re-certification, notified bodies must verify that all QMS elements were assessed during the cycle, surveillance and unannounced audits are compliant, CAPAs are resolved, and sampling plans remain appropriate.
For both product and QMS re-certifications, there should be no repetition of initial designation audits.
Implementation of the new provisions
The transitional rules are:
- For quotations, timelines, and interruptions: not retroactive to contracts signed before 25 February 2027
- For monitoring and reporting: contracts after 25 May 2027
- For re-certification, only for certificates expiring after 25 November 2027
If you have questions on how this impacts you as a manufacturer of medical devices and IVDs, contact us here or at mdlaw@obelis.net.
The public consultations of the revision of the MDR and IVDR is still open. Have your say here!
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