A fourth organisation has been designated by the MHRA as a UK Approved Body under the UK Medical Devices Regulations 2002: the UK affiliate of the EU Notified Body, DEKRA. This is the first time an organisation has been designated in this way – the other three UK Approved Bodies were UK-designated Notified Bodies under the EU medical devices framework and converted automatically to UK Approved Bodies at the end of the Brexit transition period.
Any increase in capacity due to the designation of a new UK Approved Body is welcome. However, at least in the short term, this new designation will likely have little effect on capacity for Approved Bodies to perform new conformity assessments and take on new customers. We expect that in the short term DEKRA will primarily use its new UK designation to serve its existing customers (to which it has already issued EU certificates) by issuing them with certificates allowing UKCA marking of their devices.
This still leaves a marked lack of capacity in the lead up to the coming into effect of a new regulatory framework for medical devices in Great Britain, expected to be in July 2023. Thankfully, in its recent response to the consultation on the proposed new regulatory framework for medical devices, the MHRA indicated it is minded to implement relatively generous transition periods. Under these proposed transitional provisions:
- medical devices that are UKCA marked under the current UKCA mark regime, or CE marked under the old EU Medical Devices Directive or In Vitro Diagnostics Directive, can continue to be placed on the market for three years after the new regulations come into effect (or, if earlier, the date of expiry of the certificate); and
- medical devices CE marked under the new EU Medical Devices Regulation (MDR) can continue to be placed on the market for up to five years after the coming into effect of the new Great Britain regime. It appears that this will be the case even if the MDR certificate post-dates the application of the new GB regulations.
As the new UK regulations have not yet been published, manufacturers will likely only be able to start the conformity assessment processes under the new regime around the time it becomes applicable. Even with these relatively generous transition periods, there is likely to be a bottleneck in Approved Body capacity as manufacturers try to obtain the requisite certificates during those transition periods. It is therefore understandable that the MHRA further hinted that there may be some flexibility to extend the transition periods.
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