What is the Joint Clinical Evaluations (JCA) for Medical Devices & IVDs?

Die joint clinical evaluation (Joint Clinical Assessment, JCA) is a central element of the EU-HT Assessment Regulation (EU) 2021/2282 and serves to harmonize the clinical evidence of medical devices and IVDs in the EU. It supports Member States in making market approval and reimbursement decisions and is intended to avoid duplicate testing.

Die legal basis are defined in:

• Regulation (EU) 2021/2282 (OJ L 458, 22.12.2021) — HTA basic regulation
• Implementing Regulation (EU) 2025/2086 (OJ L 202502086) — Procedure and dossier requirements
• MDR (EU) 2017/745 — Medical Devices Ordinance and
• IVDR (EU) 2017/746 — Regulation on in vitro diagnostic medical devices.

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1. Structure of the JCA dossier for medical devices

The dossier must standardized be created according to the specified template. The following Mandatory information are required:

1.1 General information

Indication: details
legal basis:

Basic UDI-DI:
Unique identifier from EUDAMED
Legal basis: MDR/IVDR

Risk class:
Classification according to MDR (I, IIa, IIb, III)
Legal basis: MDR Annex VIII

EMDN code:
Most granular level of the European Medical Device Nomenclature
Legal basis: Implementing Regulation (EU) 2025/2086, Annex I

Purpose:
Clear description of intended use
Legal basis: MDR Article 2 (12)

Brief description:
Functionality, components, duration of use, lifetime
Legal basis: Implementing Regulation (EU) 2025/2086, Section 2.1

Changes compared to previous products:
If applicable
Legal basis: MDR Article 120

AI/ML features:
For machine learning: description of algorithms and data sources
Legal basis: MDR Annex I, Chapter III

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1.2 Application Requirements

• Implementation procedures (e.g. surgical steps, training requirements).
• Organizational requirements (e.g. qualified personnel, specialized infrastructure).
• Additional consumables (non-generic components).

1.3 Regulatory status

• Approvals in other markets (USA, UK, Canada, Japan, Australia, China).
• Statements from expert committees (e.g. Clinical Evaluation Consultation Procedure (CECP) in accordance with MDR Art. 54).

2. Structure of the JCA dossier for in vitro diagnostics (IVD)

IVD-specific requirements also include:

2.1 Product-related information

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The following Mandatory information must be described in detail in the JCA dossier for IVD:

• EMDN code
• ‍Most granular level of European medical device nomenclature (e.g. specific codes for SARS-CoV-2 tests, glucose meters).→ Legal basis: IVDR Annex VI
• Detection target (analyte/marker) Precise name of the measured parameter, such as:
  • Proteins: CRP, HbA1c, PSA, SARS-CoV-2 spike protein
  • nucleic acids: HIV RNA, HPV DNA
  • Metabolites: glucose, lactate→ Legal basis: IVDR Art. 2 (2)
• Test method
  
  • Technological classification, for example:
    
    • Molecular biology: PCR, NGS, LAMP
    • Immunoassays: ELISA, CLIA, lateral flow test (rapid test)
    • Biochemistry: Enzymatic testing, electrochemistry→ Legal basis: IVDR Annex II
• degree of automation
  • Manually (e.g. single-step testing)
  • Semi-automated (mechanical sub-processes)
  • Fully automated (e.g. high-throughput laboratory systems)→ Legal basis: IVDR Annex I, Chapter II
• Quantitative/qualitative evaluation
  • Quantitatively: Measurement range (e.g. Glucose: 20-600 mg/dl), detection limit (LoD), linearity.
  • Qualitatively: Binary results (e.g. “positive/negative” during pregnancy tests).→ Legal basis: IVDR Annex I, 9.1
• Sample material
  
  • Specification of compatible samples, for example:
    • whole blood, serum, plasma
    • saliva, urine, stool
    • tissue samples (biopsies)→ Legal basis: IVDR Annex I, 9.2
• Target user base
  • laity (Self-tests for home, e.g. blood glucose meters)
  • professionals (doctors, nurses)
  • laboratory staff (highly complex systems)→ Legal basis: IVDR Annex I, 9.3

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2.2 Regulatory status

• Performance Evaluation Report (PER) upon IVDR Annex XIII.
• Approvals in third countries (FDA, MHRA, PMDA, etc.)

3. Assessment scope and evidence requirements

3.1 PICO structure (population, intervention, comparator, outcomes)

The clinical evaluation follows PICO frame:

• population: Target group (e.g. diabetics, elderly patients).
• intervention: The medical device/IVD to be evaluated.
• Comparator: Alternative treatment methods/products (if available).
• Outcomes: Clinical benefits, safety, cost effectiveness.

3.2 Systematic literature review

• databases: PubMed, Cochrane, Embase, EUDAMED.
• search strategy: Transparent documentation of search terms, inclusion/exclusion criteria.
• Study selection: Tabular overview of included studies (sorted by PICO).

3.3 Presentation of results

• Clinical effectiveness (e.g. sensitivity, specificity in IVD).
• safety data (side effects, risk management).
• Comparing with alternatives (where applicable).

4. Versioning and updating the file

The JCA dossier goes through several stages of revision. Die version history Must in the file fully documented become. Each version requires a clear naming and Justification for the amendments. The following Version types are relevant:

5.1 Version types and their purpose

• V0.1 — First SubmissionFirst version of the file sent to HTA Coordination Group (HTA-CoG) is transmitted.→ Legal basis: Article 10 (2), VO (EU) 2021/2282
• V0.2 — Update following inquiries from the CommissionAdjustments due to formal or substantive inquiries from the EU Commission or HTA-Cog.→ Deadline: Within 30 days after receipt of the inquiries (Art. 10 (5)).
• V0.3 — Adjustments following reviewer commentsRevision based on the Evaluation reports from HTA committees (e.g. additional data, clarifications) .→ Legal basis: Article 11 (2), VO (EU) 2021/2282
• V1.0 — Final public releaseApproved version without confidential trade secrets (e.g. manufacturing details, non-public studies) → Used on the EU HTA website published (Art. 21, Implementing Regulation 2025/2086).
• V1.0.1 — v2.0 — The following updatesNecessary for:
  • New clinical evidence (e.g. additional studies)
  • Amendments to the purpose,
  • Updates due to new regulatory requirements (such as MDR/IVDR updates).→ Legal basis: Art. 19, Implementing Regulation 2025/2086

5.2 Mandatory information per version

Each version must be the following metadata include:

• version number (e.g. V0.3),
• Date of creation,
• Responsible person (name, function, contact details),
• Summary of changes (brief description of why the update was made)
• Reference to previous version (e.g. “Based on V0.2 with the following adjustments:...”).

5.3 Practical tips for manufacturers

✔ Use track changes — Changes in Word/PDF with tags Make it clear.

✔ Meet deadlines — Late submissions may result in Delays in market approval lead.

✔ Check confidentiality — Before publishing as V1.0 must trade secrets be removed.

✔ Consistency with EUDAMED — Version numbers should start with UDI database entries agree.

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One early preparation and close coordination with notified bodies are decisive for a successful EU market access.

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Do you need support for a clinical evaluation of your medical device? Feel free to arrange a first non-binding appointment with us!

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