European Commission publishes implementing regulation on conformity assessments by notified bodies
The European Commission on Tuesday published an implementing regulation that outlines uniform quality management and procedural requirements for conformity assessment activities conducted by notified bodies under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).
The regulation was introduced to streamline conformity assessment activities conducted by notified bodies and to set timelines and clock-stop rules during certification processes to improve predictability and timeliness for introducing devices and diagnostics on the EU market.
This regulation is part of a larger, ongoing initiative to modify the MDR/IVDR framework, aiming to improve device availability in the EU market.
The implementing regulation will take effect on 25 February 2027, except for Article 4(4), which requires notified bodies to publish an annual report on their activities, taking effect on 1 January 2028.
The European Commission published a draft Implementing Regulation on 12 December 2025.
The regulation outlines uniform quality management and procedural requirements for conformity assessment activities conducted by notified bodies. It covers timelines for conformity assessment, interruption of timelines, monitoring conformity assessment activities, recertification of product certificates, and certification for quality management system certificates.
The Commission notes in the regulations that notified bodies have provided “inconsistent and divergent” interpretations of the regulations as well as timelines for completing conformity assessment activities and recertifications.”
“Notified bodies showed significantly differing practices when issuing quotations to manufacturers for specific conformity assessment activities,” states the regulation. “As a result, manufacturers are not provided with a reliable estimation of the overall requested services and costs. To harmonise notified bodies’ practices, this Regulation should specify the minimum information notified bodies should request to issue a quotation, to ensure that the related following applications for conformity assessment activities are not rejected because they are incomplete or because the device is outside the scope of the notified body’s designation.”
The regulation outlines mandated timeframes for notified bodies to complete various conformity assessment activities:
- The notified body must complete the review of the application and sign the contract within 30 days from the date it receives the completed application.
- Audits of the quality management system should be conducted within 120 days from the date the notified body initiates the audit.
- The assessment of the technical documentation for each device must be completed within 90 days of the notified body starting the verification process.
- The notified body has 20 days to reach a decision and issue certification, beginning the day after the final review is completed.
Additionally, for assessments of a planned substantial change to the quality management system, the regulation specifies the following timelines:
- The notified body must review proposed changes within 30 days of receiving the relevant information from the manufacturer.
In a statement issued in February 2026, MedTech Europe said the draft revision “marks an important and timely step towards reinforcing the practical functioning of the European regulatory framework for medical technologies. By introducing clearer operational provisions and expectations, it contributes to greater predictability, transparency, consistency and reliability in conformity assessment – objectives widely shared across stakeholders.”
The statement highlighted that in the past year, MedTech Europe and its members have made significant contributions to this process through workshops, structured input, and ongoing dialogue with regulators and notified bodies.
The group further noted that the Implementing Act on Annex VII should be viewed as part of a larger set of short-term improvements that will complement the upcoming targeted revisions of MDR and IVDR.
In March 2026, MedTech Europe issued a statement emphasizing that “predictable certification timelines and fees directly support timely patient access and continuity of supply. These also are a bedrock for responsible investment decisions, particularly for small and medium-sized enterprises that rely on regulatory reliability to plan development and allocate resources. In a competitive global environment, dependable regulatory pathways are essential to sustaining Europe’s innovation capacity and industrial base.”
