Published in the Official Journal of the EU on 5 May 2026, this regulation sets for the first time uniform quality management and procedural requirements applicable to notified bodies under the MDR and IVDR.
Adopted on 4 May 2026 by the European Commission, Implementing Regulation (EU) 2026/977 aims to correct the divergent practices observed across notified bodies: unpredictable timelines, opaque quotations, and re-certifications whose scope varied significantly from one body to another. It applies progressively from 25 February 2027 for new procedures, with a mandatory annual performance data publication requirement from 1 January 2028.
A hard 260-day ceiling now governs the full initial certification process.
Ceilings apply per phase:
- 30 days for application review and contract signature,
- 120 days for the QMS audit,
- 90 days for product verification, and
- 20 days for the decision and certificate issuance.
The clock can no longer be paused indefinitely while waiting for manufacturer responses.
Interruptions are capped per phase: 4 during the QMS audit, 4 during product verification. Once the allowance is exhausted, the timeline keeps running regardless of any outstanding queries.
Manufacturers are entitled to a detailed, itemised quotation before any assessment begins.
Required elements include a cost breakdown between QMS audit and technical documentation assessment, an estimate of surveillance costs, and advance notice of any cost increase exceeding 10% of the original quotation.
Re-certification is locked to a defined scope and can no longer be used as a backdoor full reassessment.
The review is confined to a set documentation package including :
- list of changes,
- PSUR,
- updated risk analysis,
- and clinical evaluation report.
Re-certification must not replicate the depth of an initial certification.
From 2028, every notified body’s performance will be publicly visible and directly comparable across the EU.
Published metrics will cover the percentage of files handled within deadlines, median duration, and median cost, giving manufacturers a factual basis to compare and select their notified body.