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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:
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.
