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Health technologies subject to joint clinical assessments

1. The following health technologies shall be subject to joint clinical assessments:

(a) medicinal products as referred to in Article 3(1) and Article 3(2), point (a), of Regulation (EC) No 726/2004, for which the application for a marketing authorisation is submitted in accordance with that Regulation after the relevant dates set out in paragraph 2 of this Article, and for which that application is in compliance with Article 8(3) of Directive 2001/83/EC;

(b) medicinal products authorised in the Union for which a joint clinical assessment report has been published, in cases where an authorisation is granted pursuant to the second subparagraph of Article 6(1) of Directive 2001/83/EC for a variation to an existing marketing authorisation which corresponds to a new therapeutic indication;

(c) medical devices classified as class IIb or III pursuant to Article 51 of Regulation (EU) 2017/745 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to Article 54 of that Regulation, and subject to selection pursuant to paragraph 4 of this Article;

(d) in vitro diagnostic medical devices classified as class D pursuant to Article 47 of Regulation (EU) 2017/746 for which the relevant expert panels have provided their views in the framework of the procedure pursuant to Article 48(6) of that Regulation, and subject to selection pursuant to paragraph 4 of this Article.

2. The dates referred to in paragraph 1, point (a), shall be as follows:

(a) 12 January 2025, for medicinal products with new active substances for which the applicant declares in its application for authorisation submitted to the European Medicines Agency that it contains a new active substance for which the therapeutic indication is the treatment of cancer and medicinal products which are regulated as advanced therapy medicinal products pursuant to Regulation (EC) No 1394/2007 of the European Parliament and of the Council ;

(b) 13 January 2028, for medicinal products which are designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000 of the European Parliament and of the Council ;

(c) 13 January 2030, for medicinal products referred to in paragraph 1 other than those referred to in points (a) and (b) of this paragraph.

3. By way of derogation from paragraph 2 of this Article, the Commission, upon a recommendation from the Coordination Group, shall adopt a decision by means of an implementing act establishing that medicinal products referred to in that paragraph shall be subject to joint clinical assessment at a date earlier than the dates set out in that paragraph, provided that the medicinal product, in particular according to Article 22, has the potential to address an unmet medical need or a public health emergency or has a significant impact on healthcare systems.

4. After 12 January 2025, the Commission, after seeking a recommendation from the Coordination Group, shall adopt a decision, by means of an implementing act and at least every two years, selecting the medical devices and in vitro diagnostic medical devices referred to in paragraph 1, points (c) and (d), for joint clinical assessment 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.

5. The implementing acts referred to in paragraphs 3 and 4 of this Article shall be adopted in accordance with the examination procedure referred to in Article 33(2).