On 17 October 2025, the European Commission adopted the Implementing Regulation (EU) 2025/2086, which establishes the rules for Joint Clinical Assessments (JCAs) of medical devices and in vitro diagnostics. This is the final of the six implementing regulations that address various procedural aspects of Regulation (EU) 2021/2282 on Health Technology Assessment (HTA), which came into force on 12 January 2025.https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202502086
Joint clinical assessments of medicinal products began in January 2025 for the high-priority categories of products, i.e. new oncology medicines and advanced therapy medicinal products (ATMPs). The relevant procedural rules were published in the Implementing Regulation (EU) 2024/1381. As of 2 September 2025, there are currently nine ongoing JCAs, five of which concern chemically-based medicinal products, two biologicals and two ATMPs. All of the products under evaluation are intended for the treatment of cancer, except for one intended to treat spinal muscular atrophy (SMA). Starting on 13 January 2028, joint clinical assessment procedures will gradually expand to include orphan medicinal products, and from 13 January 2030, all new medicines.
The final step in implementing the HTA regulation
The HTA regulation aims to assess the added value, effectiveness, costs and broader impact of healthcare interventions including medicines, medical devices and procedures. It distinguishes between activities in the clinical and non-clinical domains. JCA specifically refers to the clinical domain. It focuses on establishing the benefits of the new medicines or medical devices compared to existing products, and is performed jointly by EU member states.
JCAs do not include economic assessments or conclusions on pricing and reimbursement. These aspects form part of the non-clinical domain, alongside the ethical, organisational, social and legal aspects associated with HTA. They are all subject to national evaluation.
The new implementing regulation specifically addresses the cooperation between the core governance structure of the system, the Member State Coordination Group on HTA, and the Commission, on the one hand, and notified bodies, expert panels and health technology developers (HTDs), on the other hand. The Coordination Group is responsible for conducting JCAs and Joint Scientific Consultations (JSCs), as well as drafting the corresponding final reports. It is also responsible for identifying emerging health technologies, an information to be used as input to plan the annual work programme, and for the issuing of guidance documents. Each of these activities falls under the responsibility of a dedicated subgroup.
The work of the Coordination Group is supported administratively, technically and IT-wise by the HTA Secretariat, which was created by the EU Commission. The Coordination Group and the Secretariat mantain regular contact with the HTA Stakeholder Network, in order to facilitate dialogue with the umbrella organisations representing different perspectives on HTA. The Coordination Group, its subgroups and the Stakeholder Network are also supported by the dedicated IT platform.
The preparatory activities
Article 2 of the implementing regulation explains the process for selecting medical devices and in vitro diagnostics eligible to access the JCA procedure, once the recommendation has been adopted by the Coordination Group or selected by the Commission. The HTA Secretariat is responsible for contacting HTDs to inform and invite them to submit the information listed in Art. 3(1). This information must be provided within seven days from the obtainment of the CE certificate by the notified body or upon receipt of the request from the HTA Secretariat.
According to Art. 3(1), HTDs should provide the instructions for use, also by referring to the registration in the European database on medical device if available. The HTA Secretariat has also to inform the relevant notified body (NB) that the device has been recommended for JCA (Art. 4). In its turn, the NB must inform the Secretariat of the granting or refusal of the certificate of conformity, or the withdrawal of the certification application.
The implementing regulation also defines the flow of information regarding expert panels (Art. 5), which goes from the Secretariat to the European Medicines Agency, where the panels are hosted. The panels then express their opinion on the recommendation by the Coordination Group.
The HTA Secretariat is responsible for transmitting all the information received from the HTD, the notified body, individual experts and Member States related to JCAs and their updates to the Group, the JCA Subgroup and the assessor and co-assessor (Art. 6).The HTDs are informed of the start of the scoping process as soon as the assessor and co-assessor are appointed (Art. 7).
The HTA Secretariat compiles a list of individual experts to asses a certain device occurs by the on the basis of the indication of the medical condition to be treated, the therapeutic area, and the specific expertise needed. These are defined by the JCA subgroup according to the provisions of Article 8, after consulting other stakeholders organisations. The JCA subgroup makes the final selection of individual experts from the lists after the Commission has assessed the declared interests. The appointed experts have to sign a confidentiality agreement (Art. 9).
The JCA procedure
Once the JCA has begun, the patient and healthcare professional organisations can provide their input via the Secretariat, according to the timeframe indicated by the JCA subgroup. This can also include comments on the comparator technologies (Art. 10).
The assessor and co-assessor draft the assessment scope proposal on the basis of the information received and considering several JCA parameters in terms of patient population, intervention, comparators, and health outcome. This step in the procedure may also benefit from the report of the joint scientific consultation on the device/in vitro diagnostic, should this had been performed. Input from individual experts may also be requested.
After the proposal has been shared with the JCA subgroup, a consolidated version is produced (Art. 11). This is then discussed at a dedicated subgroup meeting (Art. 12). Finalisation of the assessment scope should be completed within 60 days of receipt of the initial information, or within 10 days of the Commission’s decision. A meeting to explain the assessment scope, with involvement of the HTD, can then be organised within 20 days (Art. 13).
The dossier for the joint clinical assessment
HTDs must submit the JCA dossier in digital form, together with any additional data or information. A template for dossiers referring to medical devices and in vitro diagnostics are provided, respectively, in Annex I and Annex II of the implementing regulation. Dossiers have to be submitted no later than 100 days after the first request is made to the HTDs. Article 14 also specifies the circumstances in which the the provided information can be integrated and updated. The Commission has 15 days to confirm that the dossier received meets the requirements of the HTA regulation for access to the JCA procedure.
The final articles of the implementing regulation deal with the drafting and sharing of the JCA reports and summary reports. Templates are provided in Annexes III to V, and the draft documents are shared with the JCA Subgroup, individual experts and HTD for comments. The latest of these actors has seven days to highlight any purely technical or factual inaccuracies, or any information deemed confidential. The finalised revised draft JCA report and summary report shall be completed within 165 days of the Commission’s confirmation of the requirements.
