By now you've probably heard rumblings about the "EU MDR and EU IVDR". The EU, like any other geographical market, has its own set of regulatory requirements for medical device registration. These requirements were recently changed to the EU Medical Device Regulations and In-Vitro Diagnostic Regulations (EU MDR and EU IVDR) and are set to go into effect on May 26th, 2021, and May 26th, 2022 consecutively. This means that all medical device manufacturers have to comply with the new EU regulations by these dates - and it's quickly approaching.
Now, it is true that about 65% of the Invitro Diagnostic Medical Device Regulation (IVDR) requirements are covered in the Invitro Diagnostic Directive (IVDD). However, even where the requirements are consistent, the IVDR is actually more prescriptive in what evidence is required to demonstrate compliance. For example, are residual risks identified in your medical device risk profile represented in the medical device labeling? This is a must under the new EU regulations.