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SubscribeThe Commission’s Implementing Regulation (EU) 2025/2086, adopted on 17 October 2025 (“Implementing Regulation”), marks a milestone in the joint clinical assessment (“JCA”) of medical devices and in vitro diagnostic medical devices in the European Union. It should be borne in mind that, since 12 January 2025, the Regulation (EU) 2021/2282 on health technology assessment (“HTA Regulation”) has been in force, establishing the legal basis for mandatory cooperation between the Member States on JCAs and joint scientific consultations.
For further information on the HTA Regulation, see our posts “Regulation (EU) 2021/2282, applicable from 12 January 2025”, as well as its development in Spain “The Draft Royal Decree on Health Technology Assessment” and in Portugal “HTA Regulation: Infarmed’s organisational and competence changes”.
This new Implementing Regulation refines and further develops that Regulation, setting out detailed procedural rules for JCAs of medical devices and in vitro diagnostic medical devices, together with standardised dossier and report formats, rules on expert participation, and parameters on transparency, confidentiality and data protection.
Details of the assessment processes
Medical devices covered by the JCAs
Medical devices and in vitro diagnosis products subject to the JCA will be those that are medical devices of class IIb or III and in vitro diagnostic medical devices of class D; and
- Present unmet medical needs;
- Be the first of their class;
- Incorporate software with artificial intelligence, machine-learning technologies, or algorithms;
- Have a relevant cross-border dimension;
- Have significant added value at Union level; or
- Have implications for patients, public health, or healthcare systems.
On the recommendation of the Coordination Group, the Commission will adopt at least every two years a decision on the selection of Products for the purposes of the JCA.
Dynamics of the assessment processes
- Product selection and information provision: The Commission’s decision to select Products for the JCA will be taken as soon as the product has obtained CE marking. The rationale is twofold: to protect the confidentiality of the certification process and to avoid parallel national assessments. At that point, health technology developers must provide detailed information on the product.
- Selection of experts: Independent experts with highly specialised knowledge will be identified to carry out the assessment.
- Scope of the assessment: A procedure is established to determine the scope of the assessment (the well-known PICO — population, intervention, comparators and health outcomes), which must reflect the needs of the Member States.
- Timelines and process management: The Implementing Regulation sets out a sequence of strict, interlinked timelines. Questions remain, however, about the feasibility of meeting milestones in complex therapeutic areas or with heterogeneous comparators, and about the capacity to absorb spikes in activity when several JCAs converge at critical phases.
- Updates and restarts: The existence of updates and the need for restarts when new clinical data become available are expressly envisaged, ensuring that conclusions are always aligned with the most recent evidence.
- Transparency, confidentiality and personal data: Finally, the JCA report and its summary are published, as was already the practice in some Member States, such as Portugal in the medicinal products sector, while ensuring information confidentiality and data protection. In the event of disagreement over information considered non confidential, an internal right of appeal for industry is provided.
Practical impact
- Heterogeneity in the European market and the acceleration of national decisions;
- The availability of JCA reports can enhance the efficiency and consistency of their processes;
- The outstanding challenge lies in the integration of JCA outcomes into national frameworks for economic evaluation.
Entry into force
The Implementing Regulation entered into force on 9 November 2025.
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