N52 - Principles of Labeling for Medical Devices (Edition 3)

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Good Regulatory Review Practices

A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Good Regulatory Review Practices Working Group is provided below for public comment.  

This version of the document includes additional considerations intended to promote the appropriate adoption of electronic labeling elements, where permitted by the regulatory authority having jurisdiction.  

Consultation documents

IMDRF GRRP WG N52 (Edition 3) final draft for Comment

Thank you for your contribution in reviewing and providing feedback for this document.

Please provide your feedback by uploading your completed comments template through the IMDRF Consultation Hub on Citizen Space by following this link. 

This comments template is also attached below. 

Comments should be limited to the use of electronic labeling elements, or to any of the other changes introduced in this version of N52.

IMDRF Affiliate Members and members of Regional Harmonization Initiatives are especially encouraged to comment on the Proposed Document contents.

Comments template for N52 consultation