Provision of information to the health technology developers on the selection of medical devices for joint clinical assessment
Article 2
1. Upon the adoption by the Coordination Group of the recommendation referred to in Article 7(4) of Regulation (EU) 2021/2282, the HTA secretariat shall take the following actions: (a) inform the health technology developers of the medical devices for which, during the period covered in the recommendation, the relevant expert panels provided a scientific opinion or their views as referred to in Article 7(1), points (c) and (d), of Regulation (EU) 2021/2282, whether or not the Coordination Group recommended to select their medical device for joint clinical assessment. Where the Coordination Group recommended to select their medical device for joint clinical assessment, the HTA secretariat shall also inform the health technology developers of the reasons for that recommendation; (b) invite the health technology developers of the medical devices recommended by the Coordination Group to be selected for joint clinical assessment to submit the information listed in Article 3(1) of this Regulation. 2. Where the Commission in its decision referred to in Article 7(4) of Regulation (EU) 2021/2282 selects for joint clinical assessment medical devices not recommended to be selected by the Coordination Group, the HTA secretariat shall without delay inform the health technology developers of those medical devices thereof and shall request the health technology developers of those devices to submit the information listed in Article 3(1) of this Regulation. The health technology developers shall provide the requested information 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. The information listed in Article 3(1) of this Regulation 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.