In most cases, Class A devices can be self-certified, unless they are sold sterile, while for Class B, C and D devices it shall be required a conformity evaluation by a Notified Body designated according to the IVDR (EU) 2017/746. It is important to underline that the 90% of IVDs, for which the “self-certification” modality is currently in place, shall be re-certified according to the IVDR Regulation.
Are you a Manufacturer of in vitro Diagnostic Medical Devices?
Fill out the form!
You will receive our White Paper directly on your inbox: a valuable help to understand the necessary actions to be taken to adapt to the IVDR and to be able to market your IVDR devices throughout Europe.