Implementing Regulation (EU) 2026/977

The European Commission has published Commission Implementing Regulation (EU) 2026/977, introducing new uniform requirements for conformity assessment activities carried out by Notified Bodies under the MDR and IVDR frameworks.

The Regulation represents an important step toward greater harmonisation, predictability and efficiency within the European regulatory system for medical devices and in vitro diagnostic medical devices.

Its objective is to support the availability of medical devices on the EU market, while promoting competitiveness and innovation across the sector without compromising patient safety.

Notified Bodies play a critical role within the EU regulatory framework, assessing device safety and performance before market access and maintaining continuous oversight throughout the product lifecycle. The new Regulation aims to ensure that these activities are carried out in a more transparent and predictable manner.

The Implementing Regulation introduces several important measures, including:

• Requirements for Notified Bodies to provide manufacturers with more reliable quotations and estimations of timelines and costs;

• Defined maximum timelines for key conformity assessment stages, including:
  – application review and contract signature,
  – quality management system audits,
  – product verification,
  – certification decisions and certificate issuance,
  – assessment of substantial changes;

• Requirements for Notified Bodies to establish systems for monitoring the duration and costs of conformity assessment activities and to publish related data annually;

• Clarified procedures and timelines for recertification activities, reducing uncertainty for both manufacturers and Notified Bodies.

For conformity assessment procedures initiated under written agreements signed AFTER 25 February 2027, the Regulation establishes the following maximum timelines:

• 30 days for application review and contract signature;

• 120 days for quality management system auditing;

• 90 days for product verification;

• 20 days for decision-making and certificate issuance.

The Regulation also defines permitted “clock-stop” mechanisms where manufacturers must respond to non-conformities, requests for clarification or additional information from the Notified Body.

In addition, specific timelines have been introduced for the assessment of substantial changes to quality management systems or device ranges:

• 30 days for review of the proposed change;

• 90 days for additional conformity assessment activities, where required;

• 20 days for issuance of certificate supplements.

The Regulation will apply from 25 February 2027 onwards for new conformity assessment procedures for which the written agreement between manufacturer and Notified Body is signed after that date.

Although the Regulation does not eliminate all potential delays — as clock-stops remain possible during the review process — it represents a significant step toward improving regulatory planning and predictability for manufacturers introducing new devices or managing substantial changes under MDR and IVDR.

This development allows companies to begin planning future regulatory strategies with greater visibility on expected review timelines and project management requirements.

MAYTAL remains available to support manufacturers in the construction and management of regulatory timelines for:

• new MDR / IVDR applications,

• substantial changes,

• certification and recertification strategies,

• coordination with Notified Bodies,

• and overall regulatory project planning.

For further information or support regarding the impact of Implementing Regulation (EU) 2026/977 on your regulatory activities, please feel free to contact our team.