Exchange of information with the notified body
Article 4
1. At the same time as it sends the information referred to in Article 2(1) to the health technology developer of the medical device, the HTA secretariat shall inform the notified body responsible for the conformity assessment of that device whether the Coordination Group recommended to select the medical device for joint clinical assessment. Where the Coordination Group recommended to select the medical device for joint clinical assessment, the HTA secretariat shall also inform the notified body of the reasons for that recommendation. At the same time as it sends the information referred to in Article 2(2) to the health technology developer of the medical device, the HTA secretariat shall inform the notified body that granted the certificate of conformity of the selection of that device for joint clinical assessment. 2. Regarding the medical devices which the Coordination Group recommends to be selected for joint clinical assessment, the notified body shall inform the HTA secretariat of the following: (a) the granting of the certificate of conformity to the device; (b) the refusal of the certification of the device; (c) the withdrawal by the health technology developer of the application for certification for the device. The notified body shall provide the information referred to in the first subparagraph within 7 days from any of the following events: (a) the granting of the certificate of conformity; (b) the refusal of the certification; (c) the withdrawal of the application for certification; (d) the receipt of the information from the HTA secretariat referred to in paragraph 1, if at the time of that receipt the certificate of conformity had been granted or refused or the health technology developer had withdrawn the application for certification. 3. Paragraph 2 shall not apply if the requested information is already duly and fully available 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.