Is there a template that could be used for CER that is in compliance with the new MDR? Considering Adverse event database for a device…would not the device sales be the denominator? If a competitor’s device is similar, for example, to a hemodialysis catheter, can literature about that device be used or excluded? Is a contract required to use that data?

A good starting point is the templates that are provided in the MEDDEV Rev 4 document and adding the differences from the MDR. We have created MDR compliant templates on a client by client basis and tailor them specifically for the client and device categories. We can’t provide a generic template, but would be happy to quote a small project to create them or provide a gap assessment between your current process and the MDR.