MDCG 2022-18 – MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of an MDR certificate.
As I am sure you are already aware, the new Article 97 basically allows you to submit a degradation request to the local competent body,
We have seen some of our clients already trying to do this; however, the regulatory authorities seem totally unprepared for this, and the Notified Body Bottleneck has simply been moved.
Have you submitted a request that has been accepted? we would love to know about your experiences.
