Can Devices That Have Already Been Certified in Accordance With The MDR Benefit From Extended Transitional Period

Jul 06, 2023 Leave a message

Yes, provided the MDD/AIMDD certificates have not been withdrawn by the notified body3 . A notified body may
withdraw a certificate if the relevant legal requirements are no longer met by the manufacturer or where a certificate
should not have been issued, taking account of the principle of proportionality. The MDR certification of the device as
such is not a reason for the notified body to withdraw a MDD/AIMDD certificate.
That means that a 'legacy device' and the corresponding MDR compliant device can be placed on the market in
parallel until the end of the relevant transitional period.

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