October 13, 2023
In addition to all the regulatory expertise shared and exchanged, as well as the networking, one of the benefits to RAPS Convergence conferences are the impromptu discussions. It was during one of these instances at RAPS Convergence 2023 (in the Exhibit Hall) that we were conversing with a notified body representative, who shall remain unidentified.
This notified body representative posited that this was one of the only times in European regulatory history in which a transfer in notified bodies would be easily feasible.
Why would a manufacturer transfer notified bodies?
We’re not necessarily advocating that manufacturers transfer notified bodies.
It will be warranted when the notified body who issued a Directive certificate for a legacy device has not been designated to the Medical Devices Regulation (Regulation 2017/745, MDR). The manufacturer in this predicament would need to secure an application for the MDR from a notified body who has been designated to the MDR before 26 May 2024, in order to benefit from the time afforded by Regulation 2023/607. To check if the notified body is designated, there is the NANDO database.
European Commission (EC) Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607, number 9.1 specifies “may occur, for example, when the manufacturer intends to make use of available capacity of another notified body e.g. when the incoming notified body has been newly designated under the MDR or when the outgoing notified body has capacity constraints.” The EC acknowledges that it may be practicable when there is “available capacity” or there are “capacity constraints”.
We have of course heard of manufacturers who are frustrated by their notified body and lack of responsiveness or customer service. Enough said.
Why would a notified body transfer be easier now?
We relied heavily on the 2006 Notified Body Operation Group (NBOG) Best Practice Guide on Change of Notified Body (2006-1). Otherwise, there was limited counsel on how to change notified bodies.
The MDR includes Article 58 related to the transfer of notified bodies (voluntary change). There is a fair amount of guidance related to a transfer of notified bodies. MDCG 2022-4 on surveillance related to Article 120 of the MDR, while not about transfer of notified bodies, presented scenarios related to surveillance and legacy and MDR devices.
The European Commission (EC) Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607, Part D, Appropriate surveillance to be performed by notified bodies includes several related responses.
Team-NB also has a position paper on the Transfer Agreement which essentially serves as a template for the agreement between the two notified bodies (tripartite agreement).
Who is responsible for surveillance according to Article 120(3)? And, when?
MDR Article 120(3e) provides that the notified body who issued the EC certificate under the Directive to be responsible for surveillance until 26 September 2024 or until the manufacturer has signed an agreement with a notified body designated under the MDR, whichever occurs first.
The transfer of surveillance responsibility from the notified body that issued the certificate under the directive to the MDR designated notified body is to be clearly defined in an agreement (tripartite).
We’re in unprecedented times.
There is now a Regulation which has required time to operationalize. Regulation 2023/607 was almost effortlessly negotiated and promulgated, now permits additional time for manufacturers of legacy devices and notified bodies to transition from the directives while avoiding shortages of medical devices.
Provided conditions are met, a manufacturer of legacy devices has until 26 May 2024 to secure an application from a notified body designated to the MDR.
As of October 2023, the notified bodies have purported capacity to accept new clients while servicing existing ones. Manufacturers should be able to leverage this increased capacity within notified bodies to ensure they have selected the most appropriate notified body for their business.
Previous Emergo by UL coverage of RAPS Convergence 2023
- Status of European Notified Bodies
- IVDR and Clinical Evidence Requirements
- Clinical Evidence and the EU MDR
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