MDCG 2024-6 Rev.0
Preliminary re-assessment review (PRAR) form template (MDR)
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.
This is the original MDCG Template that is part of the MDCG 2024-6 document Rev. 0.
Revision History
May 2024
Rev.0