Coordination for Health Technology Assessments of Medical Devices

A New Milestone in European Health Technology Assessment (HTA)

On 17 October 2025, the European Commission adopted Implementing Regulation (EU) 2025/2086, establishing detailed procedural rules for conducting joint clinical assessments (JCAs) of medical devices and in vitro diagnostic medical devices (IVDs) at Union level.

This long-awaited implementing act builds on the framework of Regulation (EU) 2021/2282 on Health Technology Assessment (HTA) and aligns it with the Medical Device Regulation (MDR 2017/745) and the IVDR 2017/746. It defines, step-by-step, how EU Member States will cooperate when evaluating the clinical performance, safety, and comparative effectiveness of innovative medical technologies.

Why This Regulation Matters

The goal of Regulation 2025/2086 is to harmonize clinical evidence assessment across Member States. Until now, medical device manufacturers often faced duplicated evaluations in each country, leading to delays and inconsistent decisions.

With this new framework, a single joint clinical assessment coordinated at EU level will serve as a reference for all Member States, improving transparency, efficiency, and predictability in market access decisions.

Key Highlights of Regulation (EU) 2025/2086

1. Structured Collaboration Across StakeholdersThe Regulation formalizes the interaction between:

   1. The Coordination Group on Health Technology Assessment (HTA);

   2. The European Commission (HTA Secretariat);

   3. Notified Bodies;

   4. Expert Panels under MDR/IVDR; and

   5. Health technology developers (manufacturers).

Each party now has defined deadlines and communication channels through the EU’s new HTA IT platform.

2. Trigger for Joint Clinical Assessments (JCAs)A medical device may be selected for JCA after CE certification, based on expert panel opinions or innovative clinical significance. The European Commission will publish the list of selected devices every two years.

   
   

3. Dossier and Template RequirementsManufacturers must prepare a standardized JCA dossier, using templates annexed to the Regulation. These templates closely mirror the clinical evaluation structure under MDR (e.g., PICO framework: Patient – Intervention – Comparator – Outcomes).

Timelines are strict:

• 7 days to provide post-certification information;

• 100 days to submit the JCA dossier;

• 165 days for completion of the assessment report.

4. Expert and Stakeholder InvolvementIndependent clinical and patient experts will participate throughout the assessment, ensuring balanced and evidence-based conclusions. The Regulation also sets conflict-of-interest and confidentiality rules for all contributors.

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6. Updates and Re-AssessmentsThe framework allows updates of JCA reports when new clinical data become available or when Member States request reassessment, ensuring continuous alignment with real-world evidence.

Practical Impact for Manufacturers

For medical device companies, this Regulation introduces new procedural obligations—but also an opportunity:

• A single EU-level clinical assessment replaces multiple national submissions.

• Transparency and predictability of evaluation timelines improve.

• Manufacturers must be ready to submit structured clinical data immediately after CE marking, coordinated through their notified body and the HTA secretariat.

Failure to meet the defined timelines may delay inclusion in the HTA work programme or postpone reimbursement decisions across the EU.

Implementation Timeline

Regulation (EU) 2025/2086 entered into force 20 days after publication in the Official Journal, i.e. on 9 November 2025. It is directly applicable in all Member States and complements earlier acts such as:

• Implementing Regulation (EU) 2024/2699 (HTA–EMA information exchange)

• Implementing Regulation (EU) 2024/2745 (conflict-of-interest management)

What Companies Should Do Now

1. Review internal clinical documentation to ensure alignment with JCA dossier templates.

2. Engage early with notified bodies and expert panels to anticipate HTA selection.

3. Prepare digital submission systems compatible with the EU HTA IT platform.

4. Coordinate regulatory and market-access teams—as HTA outcomes will strongly influence reimbursement decisions.

   
   

In Summary Health Technology

Regulation (EU) 2025/2086 marks a turning point for medical device regulation in Europe. By formalizing a common methodology and process for clinical evidence evaluation, it moves the EU closer to a truly unified health technology assessment system. For innovators, this means clearer expectations and for patients, faster access to proven, high-value medical technologies.

AF Pharma provides global regulatory support for medical devices, IVDs, cosmetics, and dietary supplements, including EU HTA and MDR compliance strategies, EU Authorized Representative, and UK Responsible Person services.

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