Team NB has finally published the long awaited template tripartite agreement for the transfer of surveillance activities of ‘legacy’ medical devices.[1] The template was first referred to in a European Commission Q&A in March 2023 as a means of promoting consistency and certainty.[2]

The template is required by any device Manufacturer relying on the EU MDR[3] extended transitional periods in respect of a ‘legacy’ device who have since changed Notified Body. The template:

1. is a tripartite agreement between the Manufacturer, the incoming EU MDR Notified Body and the outgoing EU MDD[4] Notified Body;
2. details arrangements for the transfer of surveillance activities from the outgoing Notified Body to the incoming Notified Body; and
3. is not intended to alter the terms of the contracts that the Manufacturer will have signed with each of the incoming and outgoing Notified Body.

While the drafting of the agreement leaves much to be desired, the template is not intended to be subject to negotiation and we do not anticipate significant re-writes.

We have assisted multiple clients who faced difficulty getting legacy devices to market without a tripartite agreement in place, despite it not being a statutory pre-condition to lawful placing on the market of legacy devices. The template has therefore been welcomed by our clients in that it will evidence compliance with the transitional provisions for third parties who seek reassurance that legacy devices can be placed on the market lawfully.

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[1] A ‘legacy’ device is a medical device that complied with, and is the subject of a CE certificate issued in accordance with, the EU MDD (see footnote 4).

[2] See Q13 of the European Commission’s Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

[3] Medical Device Regulation (EU) 2017/745 (as amended).

[4] Medical Device Directive 93/42/EC.