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Legacy Devices: How MDR Alters the Landscape

Posted 11 March 2020 | By Zachary Brennan 

Legacy Devices: How MDR Alters the Landscape

Medical devices with valid certifications under the Medical Device Directive (MDD) will have to prepare to adapt to the incoming Medical Devices Regulation (MDR), particularly for up-classified devices that will need more in-depth reviews from notified bodies.

So what types of manufacturers should start considering how to transition their legacy devices between MDD and MDR? Most standalone software, many orthopedic implants, and closed loop active devices, according to Gert Bos, executive director of Qserve and a RAPS board member.

Lena Cordie-Bancroft, president of Qualitas Professional Services, told Focus: “The up-classification to software as a medical device (SaMD), and particularly of apps, under MDR Rule 11 is another device group significantly affected. Per Rule 11 and the definition of ‘medical device’ in the MDR, any software that provides information that is used to make decisions for diagnostic or therapeutic purposes goes from Class I to at least Class IIa, with even more moving to Class IIb or III. This is unfortunate as Rule 11 considers severity or duration of the harm but does not take into consideration the risk. So we are seeing almost all software being affected.”

One of the key issues, according to Bos, is that for all legacy products, the quality management system needs to be ready on key elements of Article 120(3) of MDR, and implementation needs to start by the end of May. He added that notified bodies are starting to audit against it.

Concerns also remain that the limited number of notified bodies (11 designated under MDR so far) may not have the capacity to deal with legacy devices and new products simultaneously.
 
Bos noted that if notified bodies drop out, others cannot take over surveillance and certificates could lose validity during the grace period. The grace period allows certain legacy devices to be placed on the market up until 27 May 2024 and made available until 27 May 2025.
 
But Cordie-Bancroft also noted: “Notified bodies who are not seeking designation to the MDR (or IVDR) may very well face a defection of employees qualified to review medical devices and want to stay in this area. This could potentially help the designated notified bodies strengthen their capacity by providing capable resources who don’t require extensive training. Alternatively, manufactures may have experienced former-notified body employees wanting to work for them.”
 
She added that the delay in the availability of Eudamed, while not entirely unexpected, does cause some complications with the application of the Basic UDI-DI requirements to legacy devices.
 
Last April, the EU’s Medical Device Coordination Group released a four-page guidance on the registration of legacy devices in Eudamed, which includes a two-page Annex explaining how Article 120(3) of MDR lacks any specific references to UDI obligations for legacy devices.

Therefore, the MDCG “considers it appropriate to adapt the Eudamed design to allow the registration of legacy devices in Eudamed in the absence of a (Basic) UDI-DI. This is intended to prevent any technical constraint to the applicability of Art 120(3) for legacy device registration in Eudamed.”

The Annex also includes a description of the technical implications and explains basic considerations related to the future registration of legacy devices in Eudamed and technical implementation in Eudamed.

 

© 2021 Regulatory Affairs Professionals Society.

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