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10 September 2024
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16 September 2024Team Notified Body (“Team NB”) released an IVDR Notified Body Transfer Agreement. It is available: HERE
Background
This is a tripartite agreement executed between 1) the manufacturer, 2) the Notified Body that issued the IVDD 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 IVDR certification, and the new Notified Body agrees to take over the surveillance activities for the Notified Body of the IVDD legacy device.
IVDR Article 110(3e) outlines the requirements around this:
“The arrangements for the transfer of the surveillance from the notified body that issued the certificate to the notified body designated in accordance with Article 38 shall be clearly defined in an agreement between the manufacturer and the notified body designated in accordance with Article 38 and, where practicable, the notified body that issued the certificate. The notified body designated in accordance with Article 38 shall not be responsible for conformity assessment activities carried out by the notified body that issued the certificate.”
The Commission’s Q&A document provides further detail, under ‘Part D – Appropriate Surveillance to be Performed by Notified Bodies’ (questions 12-17).
This new agreement from Team NB was developed to help streamline this process.
Actions for Manufacturers
IVDD Annex II List A, List B, and Self-Test
If you have a different Notified Body for your Directive versus Regulation device and would like the new IVDR Notified Body to take over surveillance, then this agreement must be executed no later than September 26, 2025.
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. Other Notified Bodies likely follow a similar process.
IVDD “self-certified”
If you only market devices that are “self-certified” under the IVDD, but have been upclassified under the IVDR, then this transfer agreement does not pertain to you. This agreement is only required for devices that were subject to Notified Body oversight under the IVDD.
