Emergo looks at a new Q&A document detailing what custom made device manufacturers need to know to comply with European Medical Devices Regulations.
The European Medical Device Coordination Group (MDCG) has issued a new document covering key questions and considerations regarding custom-made medical devices in the context of Medical Devices Regulation (MDR) compliance.
The new MDCG Q&A document identifies 10 key questions pertaining to which devices qualify as custom-made devices, or CMDs, as well as MDR-related obligations and compliance considerations manufacturers will need to address.
Below, we discuss some of the CMD-related issues covered in the MDCG Q&A.
Read more at Emergo.