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3 November 2025
EUDAMED Officially Published Today: What Manufacturers Need to Know
26 November 2025Background
Due to a variety of reasons, manufacturers may decide to switch Notified Bodies. Manufacturers of legacy devices have special considerations, to ensure they continue to meet the MDR/IVDR transitional requirements.
Team Notified Body (Team-NB) developed transfer agreements that can be put into place between the incoming NB, the outgoing NB, and the manufacturer. This helps ensure:
- All parties clearly understand their obligations, including any key dates during the transfer process
- Manufacturers maintain their MDR/IVDR transitional provision eligibility
Team-NB has released a new agreement template, for combined transfer of MDR applications and associated legacy devices.
Overview
To date, Team-NB has published multiple transfer agreement templates.
Previous: Legacy Device Surveillance Transfer Agreement
These previous templates were created to cover the transfer of surveillance for legacy devices certified under MDD/AIMDD/IVDD.
It was applicable when:
- The MDR/IVDR application was with a different NB than the one who certified the legacy devices, and
- the manufacturer wished to transfer surveillance of its legacy devices to the NB under the MDR/IVDR application.
The new NB would then hold responsibility for both the new MDR/IVDR application, and surveillance activities for the MDD/AIMDD/IVDD legacy devices. Note that these older agreements are no longer applicable, because the regulatory deadlines have passed: 26 September 2024 (medical devices) and 26 September 2025 (IVDs).
The new template, discussed further below, addresses a different scenario: transferring the MDR application itself between Notified Bodies, with the option to also transfer surveillance for the legacy devices.
New: MDR Application (and Surveillance) Transfer Agreement
Purpose of the New Agreement
This transfer agreement addresses a specific scenario outlined in Q&A 9.1 of the European Commission’s guidance on MDR transitional provisions. Specifically, it addresses how manufacturers can switch NBs after the relevant deadlines (26 May 2024 for MDR application submission and 26 September 2024 for written agreement), while still maintaining transitional provision eligibility for legacy devices.
To ensure this: if the manufacturer or NB terminates the existing written agreement, the manufacturer must simultaneously enter into a new written agreement with a different NB. When the MDR application transfers to the new Notified Body, any surveillance of related legacy devices can be transferred along with it. This keeps the transitional period intact for the manufacturer’s legacy devices.
A common reason for switching NBs is if the incoming NB has more capacity, e.g., was newly designated under the MDR.
Important note: This option is not available if the manufacturer switches Notified Bodies because the original Notified Body refused their application due to non-compliance with MDR requirements.
What’s in the New Agreement
The new template is available: HERE
It establishes the legal framework for manufacturers to transfer both the MDR application and legacy device surveillance responsibilities.
Core Sections
The agreement includes:
- Scope and definitions of devices covered
- Signing process (manufacturer, incoming NB, and outgoing NB)
- Certification validity during transfer
- Assessment requirements before transfer
- Confidentiality and information sharing obligations
- Continued surveillance activities
- Settlement, property rights, termination, liability, and dispute resolution
- Appendix 1: Device Lists (Mandatory)
- Table 1: devices covered by the MDR formal application (subject to transfer).
- Table 2: legacy devices subject to transfer of appropriate surveillance.
- Appendix 2: Transition Provisions (Optional)
- Used if the manufacturer wants to change the notified body identification number on labelling, with a defined transition sell off period and per device / lot documentation
Note that the incoming Notified Body will review the manufacturers’ documentation before officially taking over. The NB will decide how much review they need. This may include audit reports, technical documentation, open non-conformities, and vigilance records.
In Summary
Team-NB’s new MDR Application and Surveillance Transfer Agreement provides manufacturers with a pathway to switch Notified Bodies after the original May 2024 and September 2024 deadlines have passed, while still maintaining legacy device status for its devices.
Key differences from earlier Team-NB transfer templates:
- Earlier templates: Standalone surveillance transfer only (deadlines expired)
- New template: MDR application transfer, with option to also transfer legacy device surveillance
Manufacturers must work with both incoming and outgoing Notified Bodies to execute this tripartite agreement. The transfer cannot proceed if the original NB refused the application due to non-compliance.
A version related to IVDR appliations is not yet available.
