With the adoption of Implementing Regulation (EU) 2025/2086 on 17 October 2025, the European Commission completed its legal framework for the joint clinical assessment of medical devices and in vitro diagnostic medical devices. This regulatory framework supplements the already existing Regulation (EU) 2021/2282 on health technology assessment (“HTA Regulation”) and, as the sixth implementing regulation, constitutes the final building block for the harmonisation of health technology assessment at European level.
Objectives and Framework of the HTA Regulation
The HTA Regulation was adopted on 15 December 2021 and entered into force on 11 January 2022. It establishes the legal framework for cooperation among the EU Member States in the joint assessment (Health Technology Assessment, HTA) of new health technologies. It pursues the objective of ensuring a uniform, scientifically based approach throughout the Union to the assessment of new health technologies, which in particular include medicinal products, medical devices, and in vitro diagnostic medical devices. HTA is described as an evidence-based and multidisciplinary process that evaluates the relative effectiveness as well as the additional benefit of a health technology in comparison with existing alternatives, taking into account both clinical and non-clinical aspects. The results serve national decision-makers, in particular in the area of reimbursement and market access, as a basis for health law and social law decisions.
The HTA Regulation is primarily intended to centralise clinical assessment within the EU, as assessments at national level had in part resulted in delays and duplicative efforts for companies. For this reason, the Regulation establishes a common framework with uniform rules and methods for a joint clinical assessment (Joint Clinical Assessment, JCA) and at the same time lays down the organisational structures for cooperation among the Member States, which takes place via a so-called Coordination Group. In addition, it determines the respective tasks and obligations of the European Commission, the European Medicines Agency (EMA), and the Member States within the framework of this centralised procedure. The Member States nevertheless retain their sovereignty, but benefit from uniform assessment standards and will in future be able to avoid redundant assessment procedures.
Scope of Application of the HTA Regulation
In the field of medical devices and in vitro diagnostic medical devices, the Regulation provides that certain high-risk products – in the case of medical devices in particular classes IIb and III, and selected in vitro diagnostic medical devices of class D – shall in future be subject to this EU-wide uniform joint clinical assessment.
With regard to medicinal products, the HTA Regulation provides for a phased commencement of application. Since 12 January 2025, the Regulation has already applied to medicinal products with new active substances for the treatment of cancer as well as to medicinal products for advanced therapies. Medicinal products for rare diseases will be included in the scope of application of the HTA Regulation as from 13 January 2028. All other centrally authorised medicinal products will then ultimately be covered by the substantive provisions of the Regulation as from 13 January 2030.
Content and Novelties of Implementing Regulation (EU) 2025/2086
The Implementing Regulation specifies the procedures provided for in the HTA Regulation and lays down the criteria according to which medical devices and in vitro diagnostic medical devices that have already been certified under Regulation (EU) 2017/745 on medical devices (“MDR”) or Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”) are to be included in a joint assessment procedure at EU level and assessed there. It thus creates a binding framework for the assessment of the added value of new technologies in comparison with established procedures and ensures uniform standards.
Among the essential novelties are, inter alia:
- Communication and exchange of information: The Regulation lays down the modalities in this regard between the European Commission in its capacity as Secretariat, the Member States, the manufacturers, the notified bodies, and the competent expert bodies.
- Determination of procedural rules: The Regulation defines how clinical evidence is to be collected, evaluated, and coordinated with the participating stakeholders in a uniform manner.
- Obligation to provide standardised reporting: Developers of medical devices and in vitro diagnostic medical devices are required to submit the relevant data and analyses in prescribed dossier formats and within a fixed time limit (100 days after request).
- Preparation and updating of joint assessment reports: Annexes III and IV to the Regulation lay down substantive minimum requirements for joint reporting, which ensures the comparability and transparency of assessments within the EU.
Practical Significance and Outlook
With the Implementing Regulation (EU) 2025/2086, a further central pillar for the practical implementation of the HTA Regulation is established and the traceability of the assessment process at European level is strengthened. The adopted Implementing Regulation therefore constitutes an important step towards a transparent, uniform, and efficient assessment procedure for medical devices and in vitro diagnostic medical devices in Europe. Uniform criteria and structured procedures are intended in the long term to lead to a greater alignment of market access conditions.
The new HTA system is intended to ensure high quality standards and to contribute to the harmonisation of market access, but at the same time requires the industry to undertake cross-disciplinary and timely preparation. For pharmaceutical companies, the centralised HTA system entails new methodological requirements: the central assessment at EU level lays down, in particular with regard to the preparation of assessment dossiers and the standardisation of data, strict specifications that are associated with tight deadlines. It is therefore advisable to adapt internal company processes at an early stage to the new regulatory requirements and to strengthen cooperation between legal, medical, and technical departments.
