Understanding the Draft Implementing Act on Notified Body Procedures

The EU draft implementing act December 2025 focuses on harmonising notified body procedures across the EU. This harmonisation addresses long-standing concerns about inconsistent practices that affect manufacturers’ ability to plan and budget for certification.

Key Areas Covered

Key areas covered include:

• Uniform requirements for notified bodies to ensure all operate under the same standards.

• Clear notified body procedural requirements that define how conformity assessments should be conducted.

• Rules on notified body quotation and timeline rules to standardise cost estimates and assessment durations.

• Operationalisation of Annex VII MDR IVDR implementing regulation, which details the structural and procedural obligations for notified bodies.

  
  

This draft act is a direct response to calls for more transparency and predictability in the MDR IVDR notified body practices.

How the Draft Act Affects Certification Timelines and Costs

One of the biggest challenges under the current system is the variability in certification timelines and costs. Manufacturers often face unpredictable delays and fluctuating fees, which complicate product launches and market access.

The draft Implementing Regulation on notified bodies introduces:

• Standardised conformity assessment timelines that set clear deadlines for each stage of the certification process.

• Transparent notified body costs and quotations standardisation, requiring notified bodies to provide detailed and comparable cost breakdowns upfront.

• Defined procedures for MDR IVDR re‑certification procedures, ensuring smoother renewals without unexpected delays.

  
  

By setting these rules, the EU Commission draft regulation 12 December 2025 aims to reduce uncertainty and help manufacturers plan better.

Strengthening Notified Body Quality and Operational Standards

The draft act also tightens the notified body quality management requirements. This means notified bodies must demonstrate consistent quality in their assessments and maintain robust internal processes.

Highlights of the New Standards

Highlights include:

• Clear criteria for the Annex VII operationalisation for notified bodies, which outlines the organisational structure, personnel qualifications, and procedural controls.

• Enhanced monitoring and reporting obligations to ensure ongoing compliance.

• Measures to improve transparency and predictability for notified bodies, including clearer communication channels with manufacturers.

  
  

These improvements support the broader EU medical device conformity assessment reform, aiming to raise the overall quality and reliability of notified body services.

What This Means for Manufacturers and Notified Bodies

For manufacturers, the draft act offers a more predictable path to certification. You can expect:

• More reliable timelines for product approvals.

• Transparent and comparable quotations from notified bodies.

• Clearer guidance on re-certification and ongoing compliance.

  
  

For notified bodies, the draft act means adapting to stricter operational and quality standards. This may require investments in staff training, process improvements, and enhanced documentation.

The harmonisation of notified body procedures will likely reduce discrepancies between different notified bodies, fostering a more level playing field.

How to Engage with the Draft Act

The European Commission has opened a feedback period until January 2026 draft act. This is your chance to review the proposals and provide input. Whether you represent a manufacturer, notified body, or other stakeholder, your feedback can influence the final regulation.

Steps to Participate

To participate:

• Review the full text of the European Commission proposal on notified bodies 2025.

• Identify areas where the draft may impact your operations or compliance.

• Submit detailed comments during the consultation period.

  
  

Engaging early helps ensure the final rules reflect practical realities and support smoother implementation.

Preparing for the Future of MDR and IVDR Certification

The impact on MDR and IVDR certification timelines will be significant once the draft act becomes law. You should start preparing by:

• Reviewing your current notified body contracts and timelines.

• Planning for potential changes in quotation and cost structures.

• Aligning your internal processes with the expected notified body procedural requirements.

• Monitoring updates from notified bodies about how they will implement the new rules.

  
  

This preparation will help you avoid surprises and maintain compliance as the EU moves toward a more standardised certification framework.

Conclusion

Ensure your MDR and IVDR certification strategy is aligned with the EU’s evolving rules on notified body procedures and timelines. Contact Us for practical support with gap assessments, documentation updates, and notified body interactions.

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