MDCG 2021-20 MDR临床调查civi - id生成说明.pdf

Medical Devices Medical Device Coordination Group Document MDCG 2021-20 MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations July 2021 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law. Page 1 of 6 Medical Devices Medical Device Coordination Group Document MDCG 2021-20 Introduction For clinical investigations under Regulation (EU) 2017/745 (MDR) the Competent Authorities (CAs) use Eudamed2 to obtain a Union-wide unique single identification number (the ‘CIV-ID’), upon submission of the required information to Eudamed2 (continuation of current MDD practice) see MDCG 2021-1 Rev.1. To do so, the below steps need to be followed: STEP 1 – Search /generate a Clinical Investigation ID, (CIV ID) STEP 2 – Enter the mandatory details of the related Clinical Investigation. To allow the correct registration, search and identification of the MDR Clinical investigations in Eudamed2, 3 rules apply: 1. Always start the Clinical Investigation title with “MDR” (“MDR – title”, i.e.: MDR - Detecting Traumatic Intracranial Haemorrhage with Microwave Technology) 2. Always enter the Sponsor details (t