Blink and you’ll miss it: grasping UKCA opportunities

The medical device regulatory environment is undergoing unprecedented upheaval especially in Europe and the UK. On the one hand the phased introduction of the EU MDR and IVDR are increasing pressures on manufacturers to prove the ongoing safety of their devices, if they intend to continue to place and maintain their devices on the European Market, on the other Brexit, has triggered the development of specific regulations for the UK market. As a result, there is a strong move to back away from the EU market and also the UK.

Opting to forsake the UK market, however, would not be a wise decision and, in a regulatory environment that is dominated by uncertainty, the UK still offers a great commercial opportunity for medical device manufacturers. In fact, UK device manufacturers that are already compliant with EU Medical Device Directives can, however, perform only a small amount of remediation work to UKCA mark their devices under current UK MDR 2002 (as amended). Transitional Provisions due any day now, are likely to state that manufacturers that are able to achieve UK conformity now, may be able to maintain UK market access under this scope until Summer 2027. Waiting for the delivery of new domestic approval routes with the FDA, in the USA and with PMDA, in Japan, is likely to make medical device manufacturers miss these opportunities too.

Accessing these provisions, however, requires immediate action. The window of opportunity opened by the UK MDR is in fact set to close by summer 2024. Medical devices that are UKCA conformity assessed and certified by a UK Approved Body before the new UK Regulations take effect, may in fact remain on the UK market until their Declaration of Conformity expires, or for a period of three years, up to summer 2027, depending on which takes place sooner. Although some exclusions apply, meeting the summer 2024 deadline for UKCA conformity makes excellent commercial sense.

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