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Regulation (EU) 2021/2282 SECTION 4 — Voluntary cooperation on health technology assessment

Article 23 · 1 articles

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Voluntary cooperation

Article 23

1.   The Commission shall support the cooperation and the exchange of scientific information among Member States on: (a) non-clinical assessments on health technologies; (b) collaborative assessments on medical devices and in vitro diagnostic medical devices; (c) HTAs on health technologies other than medicinal products, medical devices or in vitro diagnostic medical devices; (d) the provision of additional evidence necessary to support HTAs, in particular in relation to health technologies for compassionate use and obsolete health technologies; (e) 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. 2.   The Coordination Group shall be used to facilitate the cooperation referred to in paragraph 1. 3.   The cooperation referred to in paragraph 1, points (b) and (c), of this Article may be carried out using the procedural rules established in accordance with Article 3(7) and Articles 15 and 25 and using the format and templates established in accordance with Article 26. 4.   The cooperation referred to in paragraph 1 of this Article shall be included in the annual work programmes of the Coordination Group and the results of the cooperation shall be included in its annual reports and on the IT platform referred to in Article 30. 5.   Member States, through their designated member in the Coordination Group, may share national assessment reports on a health technology not referred to in Article 7, in particular on 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, to the Coordination Group through the IT platform referred to in Article 30. 6.   Member States may use methodological guidance developed pursuant to Article 3(7), point (d), for the purpose of national assessments.

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