EU Implementing Regulation on Joint Clinical Assessments of Medical Devices

Adopted on 17 October 2025, the European Commission issued the last of six implementing regulations on the joint clinical assessment of medical devices and in vitro diagnostic medical devices (Implementing Regulation (EU) 2025/2086, the “Implementing Regulation”). It forms part of the implementation of Regulation (EU) 2021/2282 on health technology assessment (the “HTA Regulation”).

HTA Regulation

The HTA Regulation is intended to improve EU‑wide patient access to innovative and effective health technologies through a joint assessment (health technology assessment – HTA). Health technologies include medicinal products, medical devices, in vitro diagnostic medical devices, and medical and surgical procedures.

The HTA Regulation establishes a framework under which Member States can conduct joint assessments of relevant health technologies. Together with the associated implementing regulations, it provides the basis for multidisciplinary, science-based assessments covering clinical and non-clinical aspects such as efficacy, benefits, impacts and costs. The results of an HTA serve as decision support for health authorities and payers, for example in matters of reimbursement, pricing or the introduction of new technologies. While Member States retain their decision-making authority, they can avoid duplicate assessments by using the outcomes of the joint assessment.

For medicinal products, the HTA Regulation is currently being phased in. Since 12 January 2025, the HTA Regulation applies to medicinal products containing new active substances for the treatment of cancer and to advanced therapy medicinal products. Nine joint scientific assessments are currently underway for medicinal products in these categories. From 13 January 2028, medicinal products for rare diseases will be included. From 13 January 2030, the HTA Regulation will apply to all other centrally authorised medicinal products.

For medical devices, the HTA Regulation applies only to selected products in risk classes IIb and III, as well as to selected in vitro diagnostic medical devices from class D.

EU Implementing Regulation on joint clinical assessments of medical devices and in vitro diagnostic medical devices

The Implementing Regulation specifies the criteria under which selected medical devices and in vitro diagnostic medical devices that have already been certified under the Medical Device Regulation (Regulation (EU) 2017/745, “MDR”) or the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746, “IVDR”) are included in a joint clinical assessment at EU level, and sets out the framework for such joint clinical assessments.

While the MDR and IVDR ensure the safety and performance of medical devices and in vitro diagnostic medical devices, the Implementing Regulation ensures that the evaluation of the added value of those devices – in other words, the benefit assessment benchmarking them against existing therapies – takes place in a structured, consistent and reliable manner.

Key elements of the Implementing Regulation include the following.

• Procedural rules for the joint clinical assessment. The Implementing Regulation provides how clinical evidence is to be systematically gathered, analysed and documented, and how interactions are conducted with Member States, expert panels, notified bodies, and patient and clinical experts.
• Obligation to submit assessment dossiers. The Implementing Regulation obliges developers of medical devices and in vitro diagnostic medical devices to submit the necessary information, data and analyses using standardised dossier templates within 100 days of being requested to do so.
• Preparation and use of joint clinical assessment reports. The Implementing Regulation further defines how joint clinical assessment reports and summary reports are to be prepared, with Annexes III and IV specifying the substantive requirements for those reports.

Practical implications of the Implementing Regulation

The Implementing Regulation presents a further key building block in the practical implementation of the HTA Regulation. It can significantly enhance transparency and traceability in EU assessment procedures. Unified standards and clearly regulated processes may, over time, lead to greater convergence in market access conditions across Member States. This may provide manufacturers with a degree of planning certainty.

At the same time, the Implementing Regulation introduces new obligations and additional effort for industry. The requirements for preparing assessment dossiers, standardising data and collaborating with assessment bodies call for early and thorough preparation from both a legal and technical standpoint. Manufacturers should therefore adapt their internal processes – from clinical data collection through to regulatory documentation – to the new requirements in good time.