MDCG 2021-28
Substantial modification of clinical investigation under Medical Device Regulation
Disclaimer: This document is an interactive version of the original MDCG document. We will keep it up-to-date.
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.
Acronyms
EUDAMED
GSPR
NCA
PMCF
REC
European database on medical devices
General safety and performance requirements
National Competent Authority
Post-market clinical follow-up
Research ethics committee
Introduction
The sponsor of a clinical investigation is required to submit an application/notification (1) to the Member State(s) in which a clinical investigation is to be conducted, accompanied by the documentation referred to in Chapter II of Annex XV of Regulation (EU) 2017/745 (MDR) (2). The application/notification is required to be submitted by means of the electronic system referred to in Article 73 of the MDR.
Additionally, the sponsor of a clinical investigation is required to notify (3) the Member State(s) in which a clinical investigation is being or is to be conducted if it intends to introduce modifications to a clinical investigation that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the clinical data generated by the investigation, within one week, by means of the same electronic system.
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 MDR – see MDCG 2021-8 and MDCG 2021-20.
To add to these documents, a template for ‘Substantial modification of clinical investigation under MDR’ is also provided.
Insofar as possible, the modification of a clinical investigation notification form includes same data fields to the EUDAMED system in development.
Use of the template
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 It is foreseen that this template will be withdrawn once the EUDAMED module for clinical investigations is fully functional.
Substantial modification of clinical investigation under Medical Device Regulation Template
This is the original MDCG Template that is part of the MDCG 2021-28 document Rev. 0.
Footnotes
(1): Clinical investigation application (MDR Art. 62(1)), PMCF investigation notification (MDR Art. 74(1)), other clinical investigation application/notification, i.e. a national application (MDR Art. 82(1)).
(2): Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, OJ L 117, 5.5.2017, p. 1–175.
(3): Article 75 Regulation (EU) 2017/745
Revision History
December 2021 | Rev. 0