Optimizing market access: How joint clinical assessments (JCAs) from the EU are changing the approval of medical technology and IVDs

The EU's Joint Clinical Assessment (JCA) is a milestone for medical devices and in vitro diagnostics (IVDs) — a structured, EU-wide process for generating, analyzing and evaluating clinical data that ensures safety, performance, and compliance with regulatory standards.

But what does that mean for manufacturers, healthcare systems, and patients? Let's take a closer look:

What is a joint clinical evaluation (JCA)?

A systematic, collaborative evaluation of clinical evidence for high-risk medical devices (class IIb/III) and high-risk IVDs (class D).

The goal:

• Harmonised EU-wide assessments — avoiding duplicate national reviews
• Faster market access — Using shared scientific evidence across Member States
• Increased patient safety — ensuring consistent, high-quality assessments

The legal framework: Two important EU regulations

• Regulation (EU) 2021/2282 (HTA Regulation, Dec. 2021)
• Implementing Regulation (EU) 2025/2086 (Oct. 2025)

Why is that important?

• Efficiency: One submission, 27 markets — reducing redundant national reviews
• Speed: Faster availability of innovative medical devices across the EU
• Cost savings: Reduced administrative burden for manufacturers and authorities
• Competitiveness: A more attractive EU market for medtech innovations
• Impacts on patients: Higher quality and safety in healthcare through standardized assessments

The big picture

By avoiding duplication of efforts, the JCA system pursues the following goals:

• Accelerating patients' access to cutting-edge medical technologies
• Strengthening trust in EU regulatory processes
• Reducing fragmentation in the evaluation of healthcare services

Let's talk about it! Schedule a non-binding appointment to discuss how we can help you optimize your clinical evaluation and market access strategy.