Clinical investigations shall be designed, authorised, conducted, recorded and reported in accordance with the provisions of Article 62 and of Articles 63 to 80, the acts adopted pursuant to Article 81, and Annex XV, of Regulation 745/2017.

Clinical performance studies shall be carried out in accordance with the provisions of Articles 56 to 57 and Articles 59 to 77, the acts adopted pursuant to Article 107, and Annexes XII and XIV of Regulation 746/2017.

Should be noted that the clinical investigation/performance evaluation is the subject of an authorisation by the Cyprus Medical Devices Competent Authority, since the Cyprus National Bioethics Committee has not issued a negative opinion. For more information on the National Bioethics Committee of Cyprus click here.