My bookmarksSign up free

Regulation (EU) 2021/2282 SECTION 3 — Emerging health technologies

Article 22 · 1 articles

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

Identification of emerging health technologies

Article 22

1.   The Coordination Group shall ensure the preparation of reports on emerging health technologies expected to have a major impact on patients, public health or healthcare systems. Those reports shall in particular address the estimated clinical impact and the potential organisational and financial consequences of emerging health technologies for national healthcare systems. 2.   The preparation of the reports referred to in paragraph 1 shall be based on existing scientific reports or initiatives on emerging health technologies and information from relevant sources including: (a) clinical study registers and scientific reports; (b) the European Medicines Agency in relation to upcoming submissions of applications for marketing authorisation for medicinal products referred to in Article 7(1); (c) the Medical Device Coordination Group; (d) health technology developers on the health technologies they are developing; (e) members of the stakeholder network referred to in Article 29. 3.   The Coordination Group may consult stakeholder organisations which are not members of the stakeholder network referred to in Article 29 and other relevant experts, as appropriate.

Back to Regulation (EU) 2021/2282 — full text

Articles on this page are reproduced verbatim from official open data. See the attribution line.

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

What to look at next