MDR - First Opinion of Panels in Med Device Published 🔥

As of July 2nd 2021, the first opinion of the scientific panels in the fields of medical devices has been published, regarding a resorbable implantable device that is in contact with bone.

 Note: The page, which will be updated in the future, lists the opinions provided under the Clinical Evaluation Consultation Procedure (CECP) by each of the thematic panels of the expert panels in the field of medical devices.

 The opinion follows two parts: (1) Decision of Screen experts, and (2) Scientific Opinion by the Thematic Expert Panel / Sub-Group.

 This should provide an example of future publications in this site.

 Key Takeaway:  In this case, the literature survey was flawed as the new device was similar but not equivalent to market products, and the PCMF plan needed to be extended.  Read to find out more (Under

🔗 https://ec.europa.eu/health/md_expertpanels/list-opinions-cecp_en#fragment4

 #MDROpinion #MDRG #mdrguide #IVDR #MDR #medicaldevices #ec