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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 9 CELEX: 32021R2282 Joint clinical assessment reports and the dossier of the health technology developer
1. A joint clinical assessment shall result in a joint clinical assessment report that shall be accompanied by a summary report. Those reports shall not contain any value judgement or conclusions on the overall clinical added value of the assessed health technology and shall be limited to a description of the scientific analysis: (a) of the relative effects of the health technology as assessed on the health outcomes against the chosen parameters which are based on the assessment scope as set out pursuant to Article 8(6); (b) of the degree of certainty of the relative effects, taking into account the strengths and limitations of the available evidence. 2. The reports referred to in paragraph 1 shall be based on a dossier that contains complete and up-to-date information, data, analyses and other evidence submitted by the health technology developer to assess the parameters included in the assessment scope. |
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 9 CELEX: 32021R2282 3. The dossier shall meet the following requirements: (a) the submitted evidence is complete with regard to the available studies and data that could inform the assessment; (b) the data has been analysed using appropriate methods to answer all research questions of the assessment; (c) the presentation of the data is well structured and transparent, thereby allowing for an appropriate assessment within the limited timeframes available; (d) it includes the underlying documentation in respect of the submitted information, thereby allowing the assessor and co-assessor to verify the accuracy of that information. 4. The dossier for medicinal products shall include the information set out in Annex I. The dossier for medical devices and in vitro diagnostic medical devices shall include the information set out in Annex II. 5. The Commission is empowered to adopt delegated acts, in accordance with Article 32, to amend Annex I as regards the information required in the dossier for medicinal products, and to amend Annex II as regards the information required in the dossier for medical devices and in vitro diagnostic medical devices. |