Provision of information by the health technology developer upon the certification of the device
Article 3
1. The HTA secretariat shall invite the health technology developer of a medical device that was recommended by the Coordination Group to be selected for joint clinical assessment in the recommendation referred to in Article 7(4) of Regulation (EU) 2021/2282 to provide the HTA secretariat with the following information: (a) the certificate of conformity referred to in Article 56 of Regulation (EU) 2017/745 or Article 51 of Regulation (EU) 2017/746, as applicable; (b) the instructions for use referred to in Section 23.4 of Annex I to Regulation (EU) 2017/745 or Section 20.4.1 of Annex I to Regulation (EU) 2017/746, as applicable. 2. The HTA secretariat shall invite the health technology developer to provide the information listed in paragraph 1 within 7 days from whichever of the following events happens last: (a) granting of the certificate of conformity by the notified body; (b) receipt of the request from the HTA secretariat referred to in Article 2(1), point (b). 3. If the subgroup of the Coordination Group on joint clinical assessments (‘the JCA Subgroup’) considers it necessary, the HTA secretariat shall invite the health technology developer to provide other information than the information listed in paragraph 1 necessary for the development of the assessment scope. The JCA Subgroup shall specify in the invitation whether the health technology developer is invited to provide that information in a meeting with the JCA Subgroup or in writing. 4. The information listed in paragraph 1 may be provided by referring to its registration in the European database on medical devices referred to in Article 33 of Regulation (EU) 2017/745 and Article 30 of Regulation (EU) 2017/746 when that information is already duly and fully available in that database.