Draft EU Implementing Act on Notified Body Procedure Published
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Draft EU Implementing Act on Notified Body Procedure Published
Draft EU Implementing Act on Notified Body Procedure Published
Regulatory Affairs Medical Devices In Vitro Diagnostics
Wednesday, 17 December 2025
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On December 12th 2025 the European Commission has released for consultation the draft Implementing Regulation (EU 2025) laying down certain uniform quality management and procedural requirements for the conformity assessment activities carried out by a notified body designated under Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament and of the Council
Draft EU Implementing Act on Notified Body Procedure | QbD RA Update
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The feedback period runs from 12 December 2025 to 23 January 2026. The draft regulation aims to address inconsistent practices, improve predictability, and ensure consistent conformity assessment across the EU internal market. Once adopted, the draft is expected to make Notified Body procedures more predictable and transparent for manufacturers, with clear timelines for applications, audits, product verification, and re-certification, as well as detailed cost transparency.
Key elements of the draft include:
Fixed Maximum Timelines
Notified Bodies must adhere to strict deadlines, including 30 days for application review and contract signature, 120 days for QMS auditing, 90 days for product verification, and 15 days for final decision and certification. Limits are also set on the number of interruptions allowed during these processes.
Mandatory Cost Transparency
Before issuing a quotation, Notified Bodies must collect standardised information from manufacturers and provide detailed cost breakdowns covering QMS assessment, technical documentation, surveillance costs, and potential extra costs.
Performance Monitoring
Notified Bodies must track duration and costs of conformity assessment activities, including median duration and extra costs, with annual aggregated reporting starting in 2028
Harmonised Re-certification
Manufacturers must be notified at least one year before certificate expiry, and re-certification documentation review must be completed within 60 days.
Transitional Provisions
The new rules will apply gradually. Maximum timelines and controlled interruptions do not apply to contracts signed before three months after this proposed Regulation enters into force. Requirements for Notified Bodies to monitor duration and costs apply only to contracts signed after twelve months from the entry into force of the proposed Regulation. Harmonised re-certification procedures will not apply to certificates expiring within about 18 months after the entry into force of the proposed Regulation. Annual reporting on timelines and costs will begin on 1 January 2028.
The draft regulation is intended to provide predictable, transparent, and consistent procedures for Notified Bodies and manufacturers, supporting the safe and continuous supply of medical devices and IVDs.
What does this mean for you?
For manufacturers of medical devices and IVDs, the draft Implementing Regulation signals that Notified Body procedures may become more predictable and transparent once finalised. The draft sets clear timelines for applications, audits, product verification, and re-certification, and requires detailed cost transparency from Notified Bodies. While the regulation is still a draft open for consultation until 23 January 2026, manufacturers should be aware that, once adopted, these rules will standardise conformity assessment processes across the EU, making careful preparation of submissions and timely responses to Notified Bodies increasingly important.
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