UKCA opportunity – A compelling case for UK market access and commercial opportunity
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, the pressure to develop, provide and maintain the right documentation has grown and some medical device manufacturers are considering whether it is a commercially sound decision to continue target the UK market.
Now is not the time to pull out of the UK market
For US manufacturers specifically, there is a strong move to back away from the EU market and also the UK. Alternatively, some businesses are considering whether it would be more efficient to focus energies on achieving EU MDR and IVDR compliance, as this will open up numerous national markets, than to focus activities on just the UK market. Some manufacturers are sitting, waiting but unable to plan while holding out for new domestic assurance routes to become available in coming years.
Commercial potential of the UK market for medical devices
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, the costs of preparedness for MDD to MDR transition are increasing, with greater volumes of cyclical technical documentation having to be prepared and updated for timely Notified Body submission combined with manufacturer risk and little ability to control or plan for unknown timelines and overall costs. 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).
With the new UK MDR transitional provisions to be published any day, we expect that MDD certified devices should find a smooth UK Approved Body conformity assessment with much lower cost than MDR assessment, making the UK market a highly appealing export market for international medical device manufacturers.
Potential extended market access with the UK MDR
Specifically, UKCA marking under the scope of UK MDR 2002 (as amended) is currently based on old EU Directives and as a result, the first UK MDR statutory instrument – 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, significantly extending their ability to maintain devices on the market and placing them at an advantage when, in just a few years, EU entry becomes a viable proposition once again.
A narrow window of opportunity with UKCA
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. The Government has indicated that 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, for example devices that are subject to significant changes in design or intended purpose will not be included in these provisions, meeting the summer 2024 deadline for UKCA conformity thus makes excellent commercial sense, but actions need to be taken immediately to grasp the opportunity.
Meeting UKCA conformity requirements on time
Medical device manufacturers that see this opportunity and are able to take it, will not only need to do so by Summer 2024, but will need to ensure that all post-market requirements applicable to the new UK regulatory framework are complied with from the date that the new UK Regulations enter into force.
The time is now to leverage the opportunities offered by this new regulatory environment, and deciding to withdraw to return at a later stage would most certainly result in loss of competitive edge. Partnering with regulatory environment experts that are able to see opportunity in difficult times and guide your business through the murky waters of regulatory change can help you not only keep your products on key international markets like the UK, but gain competitive advantage over those that choose to pull out due to lack of appropriate support. When extensions are announced, bottlenecks are likely to form, so taking advantage of this timely window of opportunity is key.
Contact firstname.lastname@example.org for an assessment of your needs and all the regulatory support you need to make informed exporting decisions.
Strategic Development Director