New implementing rules have been published for conformity assessment activities carried out by notified bodies, under the Medical Device Regulations. The aim of these implementing measures are to foster greater harmonisation, predictability and efficiency across the EU regulatory framework.
This marks an important step in the ongoing efforts to streamline and simplify the rules set out by the Medical Device Regulations. The aim is to support the availability of medical devices on the EU market and to further promote the sector’s competitiveness and innovation capacity, all while upholding the highest level of patient safety.
Notified bodies play a key role in the EU regulatory framework for medical devices and in vitro medical devices, assessing the safety and performance of devices before they enter the market and providing continuous oversight afterwards. Ensuring that their activities are carried out in a predictable and transparent manner is essential for well-functioning regulatory system.
The Commission Implementing Regulation (EU) 2026/977, published in the OJEU on 5 May 2026, specifies certain uniform requirements for conformity assessment activities carried out by notified bodies designated under the Medical Device Regulations.
These include:
- requirements for issuing quotations to manufacturers to provide reliable estimation of the overall requested services and costs,
- maximum timeliness and “clock-stops” for key stages, such as application review and contract signature, quality management system audits, product verification, decision and certificate issuance, and assessment of changes,
- requirements for notified bodies to establish a system to monitor the duration and costs of their conformity assessment activities and publish the information on annual basis.
- Clarified procedures and timelines for re-certification activities, reducing uncertainty for notified bodies and manufacturers.
The Implementing Regulation will apply from 25 February 2027 onwards, with the exception of the annual report on timelines and costs of conformity assessment activities which will apply as from 1 January 2028.
Excerpt from the official page. The original is authoritative.