EU Draft Implementing Regulation on MDR/IVDR Notified Bodies (2025)

On 12 December 2025, the European Commission published a draft implementing regulation (Ares(2025)11081575) introducing uniform quality management and procedural requirements for notified bodies designated under the MDR and IVDR. Open for feedback until 23 January 2026, the proposal aims to harmonize notified body practices, improve consistency, and address long-standing challenges related to quotations, timelines, and re-certification processes.

Key Objectives of the Draft Implementing Regulation  

The draft act seeks to strengthen the consistency and predictability of conformity assessment activities carried out by MDR/IVDR-designated notified bodies.

It specifically targets divergent interpretations of Annex VII of the MDR/IVDR, which have resulted in variability across notified bodies regarding timelines, information requests, and commercial practices.

Uniform Requirements for Notified Body Practices  

The proposed implementing regulation introduces more detailed requirements covering:

• Minimum information manufacturers must provide to obtain a quotation

• Clearer expectations on timelines for conformity assessment activities

• Harmonized approaches to re-certification planning and execution

• Strengthened quality management and procedural controls within notified bodies

These measures aim to ensure uniform implementation of Annex VII requirements across the EU.

Impact on Manufacturers and Notified Bodies  

If adopted, the regulation will have practical implications for both manufacturers and notified bodies:

• Manufacturers may benefit from more transparent quotations, clearer documentation expectations, and predictable assessment timelines.

• Notified bodies will be required to align internal procedures, quality systems, and client-facing processes with the harmonized rules.

Overall, the proposal aims to reduce uncertainty and delays in MDR/IVDR conformity assessments.

Public Consultation and Feedback Timeline  

The draft implementing regulation is open for a six-week feedback period, running from:

• 12 December 2025

• 23 January 2026 (midnight, Brussels time)

All feedback received during this period will be published on the European Commission website, supporting transparency and stakeholder engagement in the legislative process.

What Companies Should Do Now

Manufacturers and other stakeholders are encouraged to:

• Review the draft regulation and assess potential operational impacts

• Identify challenges related to quotations, timelines, or re-certification

• Submit structured feedback during the consultation period

• Begin preparing for possible changes to notified body interactions

Early engagement can help shape final requirements and ease future compliance.

Internal links:

• EU MDR Consulting

• EU IVDR Consulting

External links:

• European Commission draft implementing regulation – public feedback portal  

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