On May 4, 2026, the European Commission adopted Implementing Regulation (EU) 2026/977 (Official Journal of May 5, 2026). For the first time, uniform maximum time limits for conformity assessment by notified bodies are laid down across Europe.
The new maximum time limits (Art. 2) are 30 days for application review and contract signature, 120 days for the QMS audit, 90 days for product verification and 20 days for decision and certification including the Eudamed entry.
The new maximum time limits for conformity assessment by notified bodies
The QMS audit and product verification may run in parallel. Separate time limits (30/90/20 days) apply to substantial changes. Recertifications (Art. 5 to 7) must be assessed within 90 days and decided and reissued within 20 days.
Interruptions are permitted only in defined cases and with a set maximum number per phase (Art. 3). The expiry of a maximum time limit is not a valid reason to refuse a certificate.
Notified bodies must also establish a monitoring system covering compliance with the time limits, median procedure duration and median total costs within their QMS, and publish an annual report by April 30 each year.
The following key dates are relevant:
- May 25, 2026: Entry into force (Art. 9, first subparagraph).
- February 25, 2027: General date of application (Art. 9, second subparagraph). Art. 1 (quotations), Art. 2 (time limits) and Art. 3 (interruptions) apply only to procedures with a contract signed on or after this date (Art. 8(1)). The previous rules continue to apply to earlier contracts.
- May 25, 2027: Monitoring system (Art. 4(1) to (3)) for contracts signed on or after this date (Art. 8(2)).
- November 25, 2027: Recertification rules (Art. 5 to 7) apply to certificates expiring on or after this date (Art. 8(3)).
- January 1, 2028: Annual reporting obligation takes effect (Art. 4(4), Art. 9, third subparagraph).
The regulation is published here: https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj