EU Joint Clinical Evaluation (JCA) — Your checklist for an error-free dossier

The EU Joint Clinical Assessment (JCA) is here — a mandatory, harmonised review for high-risk medical products (class IIb/III) and IVDs (class D) in accordance with HTA Regulation (EU) 2021/2282.

But what does a compliant dossier look like?

Here's your quick guide to proper structuring:

Important dossier requirements

Medical devices (MDR):

• Basic UDI-DI, risk class, EMDN code
• Intended use and technical description
• AI/ML details (if applicable)
• Regulatory status (FDA, UKCA, etc.)

IVDs (IVDR):

• Target analytes (e.g. CRP, HIV RNA, glucose)
• Test method (PCR, ELISA, lateral flow, etc.)
• Sample type and user group (laymen and professionals)
• Performance Assessment Report (PER)

Clinical evidence and PICO framework

• Population, intervention, comparator, results (PICO)
• Systematic literature review (PubMed, Cochrane, EUDAMED)
• Clear safety and effectiveness data

Version management and updates

• V0.1 → First Submission
• V0.2 → Feedback after the order (30-day period!)
• V1.0 → Final public release (redacted)

Pro tip: Use change tracking, meet deadlines, and coordinate with EUDAMED to avoid delays.