When do Manufacturers of in vitro diagnostic medical devices have to conform to the IVDR (EU) 2017/746?

Manufacturers of in vitro diagnostic medical devices, currently approved, have a transitional period valid until May 26, 2022 to satisfy the IVDR (EU) 2017/746 requirements. Products already certified by a Notified Body may be placed on the market for a further 2 years under certain conditions. For example, the certificate issued under the IVDD is still valid and subject to surveillance by the Notified Body that issued it and no significant changes have been made to the device.

Considering the complexity of the IVD development process, Manufacturers of these medical devices must act well in advance to be in order when the Regulation on in Vitro Diagnostic Medical Devices (IVDR) will enter into force.

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