The European Commission has published a new Implementing Regulation introducing uniform requirements for conformity assessment activities carried out by notified bodies under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).
The new rules are intended to promote greater harmonisation, predictability, and efficiency within the EU medical device regulatory framework. They represent a significant step in ongoing efforts to streamline regulatory processes, improve access to medical devices across the European Union, and strengthen the competitiveness and innovation capacity of the medical technology sector, while maintaining high standards of patient safety.
Notified bodies play a critical role within the EU regulatory system. They are responsible for assessing the safety, performance, and conformity of medical devices before they are placed on the market and for conducting ongoing surveillance throughout the lifecycle of certified devices. Ensuring that these activities are performed consistently and transparently is essential for the effective functioning of the regulatory framework.
The new requirements are set out in Commission Implementing Regulation (EU) 2026/977, which was published in the Official Journal of the European Union (OJEU) on 5 May 2026. The regulation establishes a number of standardised requirements for notified bodies, including:
- Quotation Requirements: Notified bodies must provide manufacturers with quotations that offer a reliable estimate of the scope of services and associated conformity assessment costs.
- Defined Timelines: Maximum timeframes and permitted “clock-stop” periods are introduced for key stages of the conformity assessment process, including application review, contract signature, quality management system audits, product assessments, certification decisions, certificate issuance, and the evaluation of significant changes.
- Monitoring and Reporting Obligations: Notified bodies will be required to establish systems for monitoring the duration and costs of their conformity assessment activities and to publish this information annually.
- Recertification Procedures: The regulation clarifies procedures and timelines for recertification activities, helping to reduce uncertainty and improve planning for both manufacturers and notified bodies.
The European Commission expects these measures to improve transparency, enhance regulatory consistency across notified bodies, and provide manufacturers with greater predictability regarding certification timelines and costs.
The Implementing Regulation will apply from 25 February 2027, with the exception of the annual reporting requirements relating to conformity assessment timelines and costs, which will become applicable from 1 January 2028.
Manufacturers and other stakeholders should review the new requirements carefully and assess any potential impact on certification strategies, project timelines, and interactions with notified bodies ahead of the implementation dates.
The implementing regulation can be accessed using the following link
