Team-NB publishes two new Position Papers

Regulatory Affairs Medical Devices In Vitro Diagnostics

Monday, 17 November 2025

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Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD

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Team-NB publishes 2 new Position Papers | QbD Group Regulatory Update

5:02

On October 22nd Team-NB published two new Position Papers. One addresses changes to companion diagnostic devices under the IVDR, Annex IX, section 5.2 that require prior approval by a notified body while the other is a template agreement related to the transfer of MDR formal application and of appropriate surveillance of legacy devices specifying the terms of the transfer of MDR application(s) with, where applicable, the transfer of the appropriate surveillance activities according to Article 120 (3e) of Regulation (EU) 2017/7451 in respect of legacy devices covered by a certificate issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC.

The Team-NB Position Paper on “Changes to companion diagnostic devices under the IVDR, Annex IX, section 5.2 that require prior approval by a notified body” offers guidance on how Notified Bodies (NBs) interpret the criteria for identifying changes to Companion Diagnostic (CDx) devices that require consultation with medicinal product authorities under the In Vitro Diagnostic Regulation (IVDR 2017/746).

Under IVDR Annex IX, section 5.2(f), manufacturers must inform the Notified Body prior to making any change to a CDx device that affects its performance, intended use, or suitability in relation to the corresponding medicinal product. The NB assesses these planned changes to determine if a new conformity assessment or merely a supplement to the existing certificate is necessary.

A central focus of the document is clarifying when manufacturer-initiated changes necessitate consultation with medicinal product authorities. This consultation can be an initial consultation or a follow-up consultation. The manufacturer is responsible for determining if consultation is required and must document their justification for that decision.

The Team-NB Position Paper “ Agreement Related to the Transfer of MDR Formal Application and of Appropriate Surveillance of Legacy Devices"is a structured, official agreement template developed by Team-NB and endorsed by NBCG-Med. This position paper outlines the specific terms and modalities required to facilitate the transfer of conformity assessment activities concerning medical devices between two Notified Bodies (NBs): an Outgoing NB and an Incoming NB.

The agreement addresses two critical components under the Medical Device Regulation (MDR) transitional rules (Article 120, as amended by Regulation 2023/607):

1. Transfer of the MDR Formal Application

It specifies how the status of a formal MDR application that was lodged and accepted by the required deadline can be transferred from an Outgoing NB to an Incoming NB. The primary purpose is to ensure that, despite the transfer, the device retains the regulatory status needed to continue benefiting from the MDR transitional period.

2. Transfer of Appropriate Surveillance

It details the transfer of surveillance activities required for Legacy Devices (devices holding a valid certificate under the previous MDD or AIMDD Directives). This transfer ensures the continuity of appropriate surveillance activities, which include audits, vigilance assessments, and assessment of non-significant changes, for these legacy devices.

In essence, this agreement serves as the contractual framework that allows manufacturers to switch Notified Bodies while maintaining the legal validity of their transitional status under the MDR, ensuring continuous conformity assessment and surveillance responsibility.

What does this mean for you?

The Team-NB Position Paper on “Changes to companion diagnostic devices under the IVDR, Annex IX, section 5.2 that require prior approval by a notified body” is of direct and critical interest to manufacturers of Companion Diagnostic (CDx) devices who market or plan to market their products within the European Union (EU) or European Economic Area (EEA) because they need to know that it is their responsibility to make an assessment of the need to involve EMA based on the nature of the change; the manufacturer is responsible for determining whether a change requires a consultation with the medicinal products authority and must be able to justify their decision if they conclude that a consultation is not required.

The Team-NB “Agreement Related to the Transfer of MDR Formal Application and of Appropriate Surveillance of Legacy Devices" provides the contractual basis for a smooth Notified Body change. It ensures recognition of your MDR application transfer so transitional-period status is maintained, and it formalizes the transfer of surveillance for legacy devices. You must also provide the Incoming NB with all required documentation to complete their pre-transfer assessment and assume responsibility on the agreed transfer date.

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