COMMISSION IMPLEMENTING REGULATION (EU) 2025/2086 of 17 October 2025 laying down, pursuant to Regulation (EU) 2021/2282 on health technology assessment, procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level.

 Commission Implementing Regulation (EU) 2025/2086 just established the procedural framework for Joint Clinical Assessments (JCA) of medical devices and IVDs. Here's what this means for manufacturers.

 First: What is HTA?
Health Technology Assessment (HTA) evaluates the clinical effectiveness, safety, and value of medical technologies to inform reimbursement and coverage decisions. Think of it as the bridge between MDR/IVDR certification and actual market access.

Why this matters:
A CE mark proves safety and performance. HTA proves clinical VALUE compared to existing alternatives - essential for hospital adoption, insurance coverage, and commercial success.

 Which Devices Are Affected?
Devices selected from those that received expert panel opinions under MDR Article 106:

Class III devices (especially implantables)
Class IIb active devices for administering/removing medicinal products
High-risk, innovative devices requiring scientific opinion

 Critical Timeline Requirements:
📌 7 days: Submit certification documents after device approval

📌 100 days (+30 extension): Complete dossier submission

📌 7-30 days: Respond to information requests during assessment

📌 Total JCA process: ~345 days from certification to final report

 What Evidence You Must Prepare:
✓ Comprehensive clinical evaluation (CER for MD, PER for IVD)

✓ All studies - published AND unpublished (sponsor & third-party)

✓ Evidence structured by PICO (Population-Intervention-Comparator-Outcomes)

✓ Systematic literature reviews across multiple databases

✓ Post-market clinical follow-up plans and data

✓ Comparative effectiveness vs. relevant alternatives (not just standalone performance)

✓ Documentation following international evidence-based medicine standards

 📑 Critical Annexes - Your Implementation Roadmap
ANNEX I & II - Dossier Templates (Study These Now!)
Annex I: Complete submission template for Medical Devices (17 pages)
Annex II: Complete submission template for IVDs (13 pages)
Includes: Executive summary, methods description, results presentation, required appendices
Action: Use as checklist for evidence gap analysis

ANNEX III & IV - Assessment Report Templates
Shows exactly how assessors will structure their evaluation
Includes: Background, assessment scope, results by PICO, degree of certainty
Action: Understand assessment perspective; prepare data accordingly

 ANNEX V - Summary Report Template
Concise overview for decision-makers
Action: Draft your "story" early - how does your device improve outcomes vs. alternatives?

 Key Template Requirements:
Section 2.1: Characterization of medical condition & target population
Section 2.2: Device characteristics, mode of action, requirements for use
Section 4: Methods for systematic literature review & evidence synthesis
Section 5: Results by PICO - with uncertainties clearly documented
Appendix D: ALL underlying documentation (study reports, CER/PER, protocols, statistical analysis plans, JSC outcomes)

 💡 Strategic Implications:
1️⃣ One Assessment, Multiple Markets: Joint EU assessment accepted by all participating Member States - higher efficiency but higher stakes

2️⃣ Beyond MDR/IVDR: Clinical evidence requirements are more stringent than certification requirements

3️⃣ Early Engagement: If your device requires expert panel consultation, prepare for potential JCA selection immediately

4️⃣ Comparative Focus: You must demonstrate added value vs. current standard of care, not just safety/performance

5️⃣ Proactive Opportunities: Request scope clarification meetings, submit new data during assessment, participate in Joint Scientific Consultations

Bottom Line
For manufacturers of high-risk devices: This regulation transforms your evidence generation strategy. The templates are prescriptive - they tell you exactly what format, what depth, what comparisons are required.

 Start preparing NOW:

✅ Download and review Annexes I-V in detail

✅ Map your current evidence against template requirements

✅ Identify gaps in comparative effectiveness data

✅ Align clinical development plans with PICO framework

✅ Establish systematic processes for capturing ALL study data

✅ Consider Joint Scientific Consultation for evidence strategy

This isn't just regulatory compliance - it's your pathway to meaningful market access across the EU.

Full regulation: EUR-Lex 32025R2086