MDCG 2024-7 Rev. 1Revised Preliminary Assessment Review (PAR) Templates for MDR Now Available

The Medical Device Coordination Group (MDCG) has published revised versions of the Preliminary Assessment Review (PAR) templates and the Application Form for Notified Body (NB) designation under the MDR (Regulation (EU) 2017/745). These updates, released in January 2025, aim to improve clarity and streamline the application and assessment processes for Notified Bodies.

What’s New in the Revisions?

One of the significant changes is the removal of section G.4 from the PAR template, which was deemed redundant for Notified Bodies. This change simplifies the overall structure of the template, ensuring a more focused approach to documentation. Furthermore, the annexes have been updated to provide detailed guidance on the submission of required documents, promoting greater efficiency and accuracy during the application process.

These updates are a crucial step forward in supporting Notified Bodies as they navigate the stringent requirements of the MDR. By introducing clearer and more practical templates, the MDCG continues to enhance the regulatory framework, ensuring consistency and compliance across the European Union.

Access the Full Revised Document

The complete revised document is available for review and download. To explore all the details and ensure your processes align with the latest updates, click the link below.