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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 (Text with EEA relevance)

article  22

CELEX:  32021R2282

Identification of emerging health technologies
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.
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 (Text with EEA relevance)

article  22

CELEX:  32021R2282

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.