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IVD & MD CLASSIFICATION
12-12-2018

#IVD & MD CLASSIFICATION

How to classify your Medical Device or In Vitro Diagnostic under the new regulation

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 Regulation this approach remains.

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 IVDs the new approach will result in stricter regulatory requirements for higher class IVDs.

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


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