MDCG 2024-3 Appendix A Rev.0
Clinical Investigation Plan Synopsis Template
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.
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.
Tables - Examples
| Clinical Investigation Synopsis (Template) | |
|---|---|
| Title | [enter text here] |
| Short title | [enter text here] |
| Lay title, if applicable | [enter text here] |
| CIP number, version, and date | [enter text here] |
| EUDAMED Single Reference Number (SRN) or CIV-ID, if previously assigned | [enter text here] |
| CI modification number, if applicable | [enter text here] |
| Sponsor name and address | [enter text here] |
| Participating Location(s) and country(ies) | [enter text here] |
| Name of Investigational Device | [enter text here] |
| Clinical investigation Purpose and Background • Rationale for CI • Background of device and condition • Current standard of care | [enter text here] |
| Name of Comparator, if applicable | [enter text here] |
| Clinical development stage | [enter text here] |
| Design of the clinical investigation | [enter text here] |
| Objectives | [enter text here] |
| Primary endpoints | [enter text here] |
| Secondary endpoints | [enter text here] |
| Safety endpoints | [enter text here] |
| Exploratory / Other endpoints and outcomes | [enter text here] |
| Description of participants / study population | [enter text here] |
| Inclusion criteria | [enter text here] |
| Exclusion criteria | [enter text here] |
| Sample size | [enter text here] |
| Duration and follow up of the clinical investigation | [enter text here] |
| Statistical considerations | [enter text here] |
Note: For combination studies, more details may be relevant, such as EU number of the clinical trial, name and description of investigational medicinal product or CIV-ID/SRN of performance study of an in vitro diagnostic device.
This is the original MDCG Template that is part of the MDCG 2024-3 document Rev. 0.
Revision History
March 2024
Rev.0