Selection of individual experts for joint clinical assessments
Article 8
1. Without due delay after the adoption by the Coordination Group of the recommendation referred to in Article 7(4) of Regulation (EU) 2021/2282, the JCA Subgroup shall specify, for each medical device, the following information: (a) the medical condition to be treated; (b) the therapeutic area; (c) other specific expertise of individual experts, if needed to carry out the joint clinical assessment, including, where needed, the expertise on the type of medical device under assessment. 2. On the basis of the information listed in paragraph 1, the HTA secretariat shall identify individual experts to be consulted during the joint clinical assessment and shall compile a list of relevant individual experts, in consultation with the JCA Subgroup and the assessor and co-assessor. When compiling the list, the HTA secretariat may consult one or more of the following sources of information: (a) the members of the stakeholder network established pursuant to Article 29 of Regulation (EU) 2021/2282; (b) the European reference networks for rare and complex diseases and their respective European patient advocacy groups; (c) the portal for rare diseases and orphan drugs; (d) the national contact points designated in accordance with Article 83 of Regulation (EU) No 536/2014 of the European Parliament and of the Council ( 9 ) ; (e) the European Medicines Agency. 3. Where the consultation of the sources referred to in paragraph 2 has not yielded a sufficient number of relevant individual experts, the HTA secretariat may consult the following sources for compiling a list of individual experts: (a) other databases or directories than the ones listed in paragraph 2; (b) members of the Coordination Group and its subgroups; (c) relevant Union and international agencies and organisations. 4. After the Commission has assessed, in accordance with the rules set out in Article 5(5) of Regulation (EU) 2021/2282 and Article 4 of Implementing Regulation (EU) 2024/2745, the declared interests of individual experts in the list compiled by the HTA secretariat in accordance with paragraphs 1, 2 and 3 of this Article, the HTA secretariat shall provide the JCA Subgroup with a list of available individual experts. 5. The JCA Subgroup shall make the final selection of individual experts to be consulted during the joint clinical assessment from the list of individual experts provided by the HTA secretariat in accordance with paragraph 4. In making the final selection, the JCA Subgroup shall give priority to individual experts who have expertise across a number of Member States in the medical condition, the therapeutic area or the type of health technology that is the subject of the joint clinical assessment.