New Template Available: IVDR Transition Compliance Statement for IVDD Legacy Device Manufacturers
19 July 2024
EU Commission: New Survey to Collect Feedback from Professional Users on eIFUs for Medical Devices
1 August 2024A Notified Body confirmation template for the IVDR extension has been released. It is available: HERE
Overview
This is not a letter for manufacturers to complete. Instead, it is for Notified Bodies to issue after the manufacturer has lodged a formal IVDR application, and has a signed agreement in place with them.
Upon request, the Notified Body may issue this letter as proof that the manufacturer is meeting its obligations under the IVDR extension granted under Regulation 2024/1860.
Per the EU Commission’s IVDR extension Q&A document, it could be issued “without extra costs”. That said, some Notified Bodies may charge an admin fee to issue the letter. Please check directly with your Notified Body.
As the deadline to lodge an application is many years away for some devices, this letter may not be issuable for some time. For example, a Class B device manufacturer may need to assert they have met the May 26, 2025 deadline to implement an IVDR compliant quality system. However, they are not required to lodge an application with a Notified Body until May 26, 2027. Therefore, until that time, manufacturers can instead issue a self-declaration letter to assert they are meeting their obligations. A link to that template is provided below.
