The Medical Device Coordination Group (MDCG) has published the following updates:
| MDCG Number | Notes |
|---|---|
| MDCG 2021-20 | Instructions for generating CIV-ID for MDR Clinical Investigations The purpose of generating a CIV-ID is to create a European tracking number which can be used to identify a specific clinical investigation. A CIV-ID facilitates communication between sponsors and competent authorities, as well as between competent authorities in different member states. As there is no possibility for sponsors to generate the Single Identification Number (SIN) foreseen in the MDR before EUDAMED is fully functional, member states may encourage sponsors to obtain a CIV-ID from a Competent Authority before the first submission of application/notification. This would allow the sponsor to use the CIV-ID throughout their clinical investigation documentation wherever the SIN would have been used if EUDAMED was available. The CIV-ID may also be generated by the Competent Authority upon receipt of a first submission. |
| MDCG 2021-19 | Guidance note integration of the UDI within an organisation’s quality management system. The purpose of this document is to provide guidance on the integration of the UDI and the implementation of the UDI obligations as part of an organisation’s Quality Management System (QMS) as required by Article 10(9)(h) MDR and 10(8)(h) IVDR. Economic operators concerned include manufacturers, in the case of Article 16(1) MDR/IVDR a distributor, importer or any other natural or legal person that assumes the obligations incumbent on manufacturers, and in case of Article 22(4) MDR the natural or legal persons that assumes the obligations incumbent on manufacturers. |
| MDCG 2021-18 | Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) |
| MDCG 2021-17 | Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) |
| MDCG 2021-16 | Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR) |
| MDCG 2021-15 | Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) |
| MDCG 2021-14 | Explanatory note on IVDR codes Commission Implementing Regulation 2017/2185 establishes the codes for the designation of notified bodies in medical devices under Regulation (EU) 2017/745 and in vitro diagnostic medical devices under Regulation (EU) 2017/746. These codes are primarily used by designating authorities to define the notified body (NB) scope of designation but they are also used by the NB to: 1) describe the individual qualification of the NB’s staff members 2) describe the qualification required for assessing a device. |
| MDCG 2021-13 | Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR. You can read more about this document in a previous post here. |
MDCG 2021-13, 14,19 and 20 can be downloaded by clicking on the links above. The rest of the documents are available here under the heading ‘Notified bodies’.
Source: Europa website