Team-NB Revises its Position Paper on Transfer Agreement for Surveillance of Legacy Devices
19 July 2024
On 2 July 2024, Team-NB, The European Association of Medical Devices Notified Bodies, published a revised position paper on a transfer agreement for the surveillance of legacy devices, first version dated 14 August 2023. The position paper specifies the terms for the transfer of the corresponding surveillance activities in accordance with Article 120(3e) of Regulation (EU) 2017/745 in relation to legacy devices covered by a certificate issued according to Directive 90/385/EEC or Directive 93/42/EEC.
In line with (EU) 2017/745/MDR Article 120(3e), third subparagraph, an application must be submitted containing a written agreement between the manufacturer, the incoming notified body (notified body responsible for MDR approval) and, where applicable, the outgoing notified body issuing the MDD/AIMDD certificate. This agreement defines the modalities for the continuous transfer of surveillance of existing products falling under Article 120(3c)(e) of the MDR.
The position paper also contains questions and answers from the European Commission relating to such topics as:
- Implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 with regard to transitional arrangements for certain medical devices and in vitro diagnostic medical devices
- Guidance on the transfer of surveillance of existing devices from the notified body that issued the MDD/AIMDD certificate to the notified body of the MDR (Part D of the position paper).
Finally, the position paper includes a checklist for manufacturers containing documents required for the incoming and outgoing notified body.