We are pleased to inform you that on 17 October 2025, the Commission Implementing Regulation (EU) 2025/2086 was adopted. This Implementing Regulation, pursuant to Regulation (EU) 2021/2282 on health technology assessment, lays down procedural rules for the interaction during, exchange of information on, and participation in, the preparation and update of joint clinical assessments of medical devices and in vitro diagnostic medical devices at Union level, as well as templates for those joint clinical assessments was adopted.
The document is available at the following link:
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202502086
The European Commission has published answers to frequently asked questions regarding Regulation (EU) 2021/2282 on health technology assessment. The document is available at the following link:
https://health.ec.europa.eu/latest-updates/frequently-asked-questions-about-joint-clinical-assessments-2025-09-05_en
We are pleased to inform you that all procedural guidance, templates, and guidelines related to the Joint Scientific Consultations (JSCs) for medicinal products (MPs), medical devices (MDs) and in vitro diagnostic medical devices (IVDs) are now available. Details of the full process and the relevant documents can be found below:
Joint Scientific Consultation (JSC) – process overview
Structure of documents related to health technology assessment and joint scientific consultations under Regulation (EU) 2021/2282“
26.03.2024 We are pleased to inform you, that the European Commission published the first two methodological guidance documents on its website under “Key documents”. These guidance documents were developed within the subgroup of the methodological and procedural guidance and they were endorsed by the HTA Coordination Group on 8 March 2024.
The documents are based on guidances developed within EUnetHTA21 where they were subject to public consultations.
- Methodological Guidance for Quantitative Evidence Synthesis: Direct and Indirect Comparisons
- Practical Guidance for Quantitative Evidence Synthesis: Direct and Indirect Comparisons
The guidances are available here:
https://health.ec.europa.eu/health-technology-assessment/key-documents_en?f%5B0%5D=topic_topic%3A225&f%5B1%5D=topic_topic%3A226&f%5B2%5D=topic_topic%3A227&f%5B3%5D=topic_topic%3A228
The HTA Regulation (EU) 2021/2282 provides a transparent and inclusive framework by establishing a HTA Coordination Group. It is the main governing body within which joint clinical evaluations and joint scientific consultations will be carried out, both for medicinal products and for medical devices. The main tasks of the HTACG are to coordinate and adopt the joint work on HTA carried out by its sub-groups within the scope of this Regulation and to adopt methodological and procedural guidance documents for joint work. The HTACG also aims to ensure cooperation between relevant bodies of the European Union (e.g. the European Medicines Agency), as well as the appropriate participation of stakeholder organizations and experts in its work. The National Council for Prices and Reimbursement of Medicinal Products is the representative of Bulgaria in the Coordination Group, as well as a member in all its subgroups.