Contents
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.
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