Hello,
As Richard mentioned, the classification rules under the UK MDR 2002 are based on the EU MDD. The MHRA's guidance on class I medical devices still references Meddev 2.4/1 rev. 9:
https://www.gov.uk/government/collections/guidance-on-class-1-medical-devices
As you mention, many SaMDs are currently expected to be up-classed under the new UK regulations. However, devices already UKCA marked prior to the new regulation will have a transition period to comply. Therefore, if you UKCA mark your device (and subsequently register it with the MHRA, via your UK Responsible Person if you are not located in the UK), then you will be eligible for the transition period.
https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations
"After careful consideration of responses, it remains the government's intention to introduce the transitional arrangements for UKCA marked devices, as set out below, with patient safety as the first priority. This would apply to general medical devices and IVDs that hold a valid certification/declaration of conformity to the UKCA standard, before the new regime takes full effect.
The government would like to establish a transitional arrangement for these products which will allow, at a minimum, products to be placed on the market until either the certificate expires or for three years after the new regulations take effect (in the case of general medical devices) or five years (in the case of IVDs), whichever is sooner.
The caveats that will apply to this arrangement are:
- devices that are subject to significant changes in design or intended purpose will be excluded from these provisions
- all post-market requirements applicable to the new regulatory framework will need to be complied with for all products which benefit from the transitionary arrangements"
Therefore, there may a distinct advantage to UKCA mark, if the device is Class I self-cert under the current scheme, but will be up-classed under the new UK regulations (and is up-classed under the EU MDR).
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Sydney O'Connell
Director of Global Representation
www.casusconsulting.com
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Original Message:
Sent: 15-Feb-2023 23:02
From: Anonymous Member
Subject: SaMD per UK MDR 2002
This message was posted by a user wishing to remain anonymous
Hi,
Has anyone had experience placing a SaMD on the UK market per UK MDR 2002? It appears that registration of Class 1 SaMD is a possibility under UK MDR 2002 like it was per the MDD. This is an attractive strategy to enter the UK market for the time being before the new UK regulations come into effect in 2024 (at which point most SaMD will likely be up-classified to Class IIa like it did with the EU MDR).
Also, do let me know if the community has any recommendations on UK consults with expertise in this area?
Many thanks!