Medical device legacy status: new definition and requirements
In March the European Commission reached a decision regarding the MDR/IVDR transition period that has been extend until 31st December, 2027 or 31st December, 2028, as applicable[1].
The MDR/IVDR Amendment, Regulation 2023/607 (Transitional Provisions)[2] was published on 20th March, 2023, and immediately entered into force. Among other elements, this amendment changes the definition of a legacy device in such a way that requires manufacturers to take immediate action to avoid losing their medical device legacy status.
Legacy devices and transitional period
A Q&A Document[3] made available by the European Commission states that only legacy devices can benefit from the extended transitional period. According to this document, legacy devices should be understood as class I devices being up-classified and devices covered by a valid EC certificate issued prior to 26th May, 2021, which, in accordance with the MDR’s transitional provisions, are placed on the market after the MDR’s date of application (i.e. 26th May 2021).
To benefit from the extended transitional period after May 2024, manufacturers need to submit a formal application for MDR certification with a Notified Body by 26th May 2024, after which any chance to maintain their devices’ legacy status will be lost.
Legacy device certification requirements
To submit an application for MDR certification for legacy devices, manufacturers need to make sure they have all their documentation ready and up to date, including readiness of QMS, post market obligations and anything else the NB could ask to review. Specifically, manufacturers must draw up the documentation on their device’s QMS, such as post-market surveillance, market surveillance, vigilance and registration, which needs to be part of their application for conformity assessment, even though the conformity assessment may happen a long time later.
In addition to a MDR certification, manufacturers that intend to maintain their devices’ legacy status need to enter into a signed agreement with their appointed NB before 26th September, 2024.
Legacy devices: a time for action
Preserving medical devices legacy status might make the difference between commercial success or failure for many manufacturers, that should start preparing to submit a MDR certification application right now to avoid potential bottlenecks closer to the May 2024 deadline.
With little more than a year to avoid losing legacy status and increasing Notified Body capacity issues, in fact, manufacturers that decide to delay their application risk losing their chance to benefit from the extended transitional period and having to re-apply for MDR certification after 26th May, 2024, when NBs will surely be at full capacity.
Contact us via email at hello@imedconsultancy.com or call us at +44 (0)1295 724286 to find out how IMed Consultancy can support you in applying for MDR certification!
[1] Extension of the MDR transitional period and removal of the ‘sell off’ periods – Q&A on practical aspects
[2] MDR/IVDR Amendment, Regulation 2023/607 (Transitional Provisions)
[3] Extension of the MDR transitional period and removal of the ‘sell off’ periods – Q&A on practical aspects
Matt Burton
Strategic Development Director