MDCG updates - December 2021

The Medical Device Coordination Group (MDCG) has published the following updates:

MDCG number	About the guidance
MDCG 2021-28	Substantial modification of clinical investigation under Medical Device Regulation In the absence of the European database on medical devices (EUDAMED), a series of clinical investigation application/notification documents have been created to support clinical investigation procedures with respect to the Medical Devices Regulation (EU) 2017/745. To add to these documents, this template (MDCG 2021-28) for ‘Substantial modification of clinical investigation under MDR’ is provided. Insofar as possible, the modification of a clinical investigation notification form includes same data fields as the EUDAMED system in development This document is intended to be facilitative and its use by the Competent Authorities and sponsors is encouraged. However it is important to check with the individual Member State in which the clinical investigation is taking place or planned to be conducted as to any specific national requirements. It is foreseen that this template will be withdrawn once the EUDAMED module for clinical investigations is fully functional.
MDCG 2021-27	Questions and Answers on Articles 13 & 14 ofRegulation (EU) 2017/745 and Regulation (EU) 2017/746 This document presents Q and As on requirements related to importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The questions covered by the document aim to provide further detail on the operational and practical implementation of Articles 13 and 14 and other related obligations for importers and distributors under the Regulations. Activities described in Article 16 of the Regulations are covered in other guidance documents.

MDCG number

About the guidance

MDCG 2021-28

Substantial modification of clinical investigation under Medical Device Regulation
In the absence of the European database on medical devices (EUDAMED), a series of clinical investigation application/notification documents have been created to support clinical investigation procedures with respect to the Medical Devices Regulation (EU) 2017/745.
To add to these documents, this template (MDCG 2021-28) for ‘Substantial modification of clinical investigation under MDR’ is provided.
Insofar as possible, the modification of a clinical investigation notification form includes same data fields as the EUDAMED system in development
This document is intended to be facilitative and its use by the Competent Authorities and sponsors is encouraged. However it is important to check with the individual Member State in which the clinical investigation is taking place or planned to be conducted as to any specific national requirements.
It is foreseen that this template will be withdrawn once the EUDAMED module for clinical investigations is fully functional.

MDCG 2021-27

Questions and Answers on Articles 13 & 14 ofRegulation (EU) 2017/745 and Regulation (EU) 2017/746
This document presents Q and As on requirements related to importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

The questions covered by the document aim to provide further detail on the operational and practical implementation of Articles 13 and 14 and other related obligations for importers and distributors under the Regulations. Activities described in Article 16 of the Regulations are covered in other guidance documents.