The attachment provides a flowchart that intends to assist manufacturers and other relevant actors in deciding whether a device is covered by the extended transitional period owing to Regulation 2023/607.

The flowchart is divided into two parts:

Part 1: “Legacy devices” pursuant to Article 120(3a) MDR or 120(3b) MDR
Part 2: Class III custom-made implantable devices referred to in Article 120(3f) MDR
For those interested in the flowchart, please refer to the attachment.



Flowchart to Assist in Deciding Whether or Not a Device is Covered by the Extended MDR Transitional Period