Team Notified Body (“Team NB”) released a new version (v2) of the Transfer Agreement. It is available here.

Background

This is a tripartite agreement executed between 1) the manufacturer, 2) the Notified Body that issued the MDD/AIMDD legacy device CE Certificate, and 3) the Notified Body that is taking over market surveillance activities for that legacy device.

This scenario would occur if the manufacturer has selected a new Notified Body for their MDR certification, and the new Notified Body agrees to take over the surveillance activities for the Notified Body of the MDD/AIMDD legacy device.

MDR Article 120(3e) outlines the requirements around this. It is also reiterated in MDCG 2022-4:

“…arrangements for the transfer of the appropriate surveillance need to be defined in an agreement between the manufacturer, the MDR notified body and, where practicable, the notified body that issued the MDD or AIMDD certificate.”

The Commission’s Q&A document (Questions 13 & 14) provides further detail, including what “where practicable” implies.

Team NB developed this template to help streamline this process.

Actions for Manufacturers

If you have a different Notified Body for your Directive versus Regulation device, and would like the new MDR Notified Body to take over surveillance, then this agreement must be executed no later than September 26, 2024.

If you would like to do this, but have not yet requested it, you are recommended to contact the Notified Body ASAP.

BSI has a flowchart of their process to transfer surveillance to them, which may be a helpful resource. It is on page 3 of their leaflet, available here. Most Notified Bodies likely follow a similar process.