As many manufacturers currently know, there are many conditions that you must satisfy in order to be eligible for the extension in transitional periods. Although these conditions are stated on the EU 2023/607 document, reading through these conditions, and subsequently determining the applicability could get confusing, and at times hard to follow. In light of this, a flowchart has published with the aim of assisting manufacturers in deciding whether a device is covered by the extended transitional period.
The flowchart is conveniently divided into two parts;
- The first part deals with legacy devices referred to in Article 120 (3a) and (3b) of the MDR, i.e., devices covered by a certificate issued by the notified body and devices which under the MDD did not require any certificate and now under the MDR require the involvement of a notified body as part of their conformity assessment respectively.
- The second part deals with Class III custom-made implantable devices, referred to in Article 120(3f) of the MDR.
The flowchart is a very useful tool for manufacturers and helps in providing a visual step by step approach in determining the applicability of the new amendments to the transitional periods. We would urge all manufacturers who are unsure whether their device is within the scope of the extension to use this chart.
The flow chart can be accessed using the following link.
