Enhancing Consistency and Quality: IMDRF Releases Guidance on Medical Device Regulatory Review Reports

A new guidance document has been released by the International Medical Device Regulators Forum (IMDRF) that focuses on the development of a medical device regulatory review report. The purpose of this document is to outline the specific information that Conformity Assessment Bodies should examine when evaluating a regulatory submission. By providing clear guidelines, this guidance document aims to enhance the consistency and quality of the evaluation process.

🔗 Original Document:  https://www.imdrf.org/sites/default/files/2023-02/IMDRFGRRP%20WGN71%20Guidance%20Regarding%20Information%20to%20be%20Included%20_%20GRRP%20_%20Final%20%281%29_0.pdf