On 10 June 2026, the European Association of Medical Devices Notified Bodies (Team-NB) adopted a new Position Paper entitled:

“Agreement Related to the Transfer of IVDR Formal Application and of Appropriate Surveillance of Legacy Devices”

The document provides guidance on the transfer of formal applications submitted under Article 110(3e) of Regulation (EU) 2017/746 (IVDR) and, where applicable, the transfer of appropriate surveillance activities for legacy devices covered by certificates issued under Directive 98/79/EC (IVDD).

The Position Paper aims to support a harmonized approach among notified bodies when manufacturers decide to transfer their IVDR application from one notified body to another. It outlines the responsibilities of the transferring and receiving notified bodies, the information to be exchanged, and the conditions under which surveillance activities related to legacy devices may also be transferred.

As the IVDR transition continues, this guidance contributes to greater consistency, transparency, and predictability for manufacturers and notified bodies involved in transfer processes.

MDSS welcomes initiatives that facilitate a smooth implementation of the IVDR and support the continued availability of safe and effective in vitro diagnostic medical devices on the European market.

Download the full Team-NB Position Paper here.