Medical Devices have been classified under the Medical Device Directive as 1, 1m, 1s, 2a, 2b and 3. With the increase of the class, the inherent risk increases too. As a result, the regulatory requirements will increase too, not only in number but also in nature. Under the new Medical Device
For In Vitro Diagnostics the new IVD Regulation will also apply a risk-based approach, which could be regarded as a paradigm shift with respect to the IVD Directive. The classes for IVDs range from A to D, with D the highest risk class. Also for
To assist you in your efforts to classify your IVD or Medical Device we have put the criteria according to these novel regulations in a flowchart.
Feel free to contact us in case of additional questions!
View chart here. (Info: Chart has been updated according to the new MDR)
Contact: Marc Klinkhamer - Principal Consultant at Xendo