3. Key elements of the HTA regulation


Key elements of the HTA regulation

    • Establishment of a Member State Coordination Group on Health Technology Assessment (the ‘Coordination Group’) composed of Member States’ representatives, in particular from HTA authorities and bodies with responsibility for overseeing the carrying out of joint clinical assessments and other joint work within the scope of this Regulation. (Article 3)
    • Joint clinical assessments
      • for medicinal products falling under the centralised procedure (Article 3(1) and Article 3(2), point (a), of Regulation (EC) No 726/2004)
      • certain classes of Medical Devices and in vitro diagnostic medical devices (IVDs) (Article 7) (see below)
    • Joint scientific consultations for health technology developers with the Coordination Group in order to exchange information on their development plans for a given health technology. Those consultations serve to facilitate the generation of evidence that meets the likely evidence requirements of a subsequent joint clinical assessment on that health technology. They shall in particular concern all relevant clinical study aspects. Clinical studies comprise clinical trials of medicinal products, clinical investigations required for the clinical evaluation of Medical Devices and performance studies required for performance evaluations of in vitro diagnostic medical devices. (Article 16)
    • Identification of emerging health technologies (‘horizon scanning’ to allow the early identification) and preparation of reports on such technologies expected to have a major impact on patients, public health or healthcare systems. (Article 22)
    • Voluntary collaboration on health technology assessment. The Commission shall support and the Coordination Group shall be used to facilitate the cooperation and the exchange of scientific information among Member States on:
      • non-clinical assessments on health technologies;
      • collaborative assessments on Medical Devices and IVDs;
      • HTAs on health technologies other than medicinal products, Medical Devices or IVDs;
      • the provision of additional evidence necessary to support HTAs, in particular for health technologies for compassionate use and obsolete health technologies;
      • clinical assessments of health technologies referred to in Article 7 for which a joint clinical assessment is not yet initiated and of health technologies not referred to in that Article, in particular health technologies for which the report on emerging health technologies referred to in Article 22 has concluded that they are expected to have a major impact on patients, public health or healthcare systems. (Article 23) [1].

The HTA regulation will designate a subset of Medical Devices and IVDs to systematic ‘joint clinical assessments’ at the EU level, in which the device will be compared to other health technologies or solutions. These products must have undergone prior CE marking in the framework of the MDR or IVDR. Such joint clinical assessments will look specifically at the clinical aspects of new products, i.e. safety and effectiveness data, from regulatory documents generated under the MDR and IVDR. Clinical assessments are typically based on global evidence derived from worldwide clinical trials in the case of medicinal products and multi-national clinical trials for Medical Devices and IVDs.

The Medical Devices and in vitro diagnostic medical devices (IVDs) that are in the scope of this process according to Article 7 (in paragraph 1, points (c) and (d)) are:  

    • Medical Devices classified as class IIb or III according to Article 51 of Regulation (EU) 2017/745 for which the relevant expert panels have provided a scientific opinion, and subject to a selection process*.
    • in vitro diagnostic medical devices classified as class D according to Article 47 of Regulation (EU) 2017/746 for which the relevant expert panels have provided their views, and subject to a selection process*.

*The selection process as described in Article 7 (4) is based on one or more of the following criteria:

a) unmet medical needs;

b) first in class;

c) potential impact on patients, public health or healthcare systems;

d) incorporation of software using artificial intelligence, machine learning technologies or algorithms;

e) significant cross-border dimension;

f) major Union-wide added value.

The HTA regulation does not impact Member States' current responsibility for the management of their health services, including pricing and reimbursement. This means that while Member States must take the joint clinical assessment results, conducted under the HTA regulation, into account, the output of the clinical assessment is not binding. This is because other national aspects, which may differ between Member States (e.g., health system specific regulations pertaining to pricing and reimbursement, and insurance systems), must be included in the final HTA-recommendation on whether to implement the new health technology at the national level.



[1] Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021R2282