Scottish Health Innovations Ltd (SHIL) works in partnership with NHS Scotland to identify, protect, develop and commercialise new innovations from healthcare professionals. Registered Number: SC 236303. Registered address: Scottish Health Innovations Ltd, 272 Bath Street, Glasgow, G2 4JR
UKCA compliance – getting your regulatory house in order for June 2023 and seizing competitive advantage
Head of Regulatory Affairs at Scottish Health Innovations Ltd, Elaine Gemmell discusses
The regulatory landscape is undoubtedly in flux – and with some big changes coming, now is the best time to proactively take vital action to get your house in order.
A key change for medical device manufacturers is the ending of the Brexit transition period – and with it, the seismic shift which occurred. Fundamentally, the CE mark will cease to be recognised in the UK after 30 June 2023, meaning that manufacturers that have or want to introduce products into the UK market will need a UK Conformity Assessed (UKCA) mark instead of a CE mark.
The date is especially vital to note given the government’s announcement last August stating that the deadline to transition from CE to UKCA Marking had been extended, giving the market additional time to adjust. There will not be another opportunity.
So, what exactly is UKCA Marking?
Primarily, UKCA Marking is a new UK product marking that is used for goods being placed on the market in Great Britain (England, Wales and Scotland), covering most goods which previously required the CE Marking.
Essentially, it is a mark signifying compliance with UK Directives which require specific standards of performance, quality, safety, and efficacy to be met.
Alongside regulatory changes, the medical device industry has also seen unprecedented growth over the course of the pandemic. This has meant that regulators have had to become more flexible against a backdrop of fast-changing advances in science and technology. This growth shows no signs of slowing down with vast opportunities to support NHS recovery.
This has produced a complex, multi-faceted scenario. Indeed, with the new Medical Device Regulation coming into force across Europe, due to delays in implementation of the new European legislation, the UK chose to retain pre-existing rules while also introducing mechanisms to allow it to draw up separate rulings for the sector in the future.
With that in mind, consultation on future medical device regulation in the UK took place in late 2021. This will result in more stringent regulation, with the prospect of a standardisation of procedure to be particularly welcomed.
In its own words, the Medicines and Healthcare products Regulatory Agency (MHRA) is working to develop a “world-leading future regime for medical devices that prioritises patient safety while fostering innovation.”
Before the pandemic, there was already movement towards increased governance around medical device innovation. Now, however, far-reaching new regulations are having a significant impact on everyone involved with medical devices – from their manufacture to their use.
A strong understanding of regulatory compliance must therefore be intertwined with the development process early on when attempting to harness the true potential of new innovations.
Innovators have to be supported in their grassroots understanding of what is required of them from a compliance point of view, so that good practice is inherent in product development strategies and the criteria required for regulation will have already been met when products are ready to release to the market.
With that in mind, the NHS has a key role to play in supporting the development and deployment of innovative medical devices that offer real value over existing solutions, are compatible with NHS systems, and can be safely deployed in clinical practice – so it, along with partners, must also take a strong lead on spreading the UKCA marking message.
The only exception to the UKCA marking rule is that CE marking will continue to be required for devices placed on the Northern Ireland market and EU rules will need to be met.
To place a CE mark on a medical device for circulation in both Northern Ireland and the EU, manufacturers must use an EU-recognised notified body to undertake any mandatory third-party conformity assessment. The results of conformity assessments carried out by UK-notified bodies will not be recognised within the EU
Designated UK Notified Bodies appointed by MHRA will be able to conduct conformity assessments for the purposes of the Northern Ireland market in isolation. For these products, in addition to the CE marking, device manufacturers will also need to apply the UKNI marking It is further important to note that products with the CE and UKNI marking cannot be sold in the EU.
If products require a mandatory third-party conformity assessment (and not self-declaration), the subject entity will need to use an EU Notified Body and can then CE mark products prior to circulation. Several areas of the regulations require clarification from the competent authorities. CE certificates issued before 1 January 2021 will remain valid for the GB Market until 30 June 2023. If there is a change or update to the device, the relevant UK approved body will need to issue a new UKCA certificate to replace the CE certificate.
For medical devices that require assessment as part of the conformity assessment route, manufacturers apply to a UK approved body. Following an appropriate assessment, the approved body will issue relevant certification allowing manufacturers to place UKCA marking on their products and place them on the market in Great Britain.
The good news is that the technical requirements you must meet – and the conformity assessment processes and standards that can be used to demonstrate conformity – are largely the same as they were for CE marking. However, there are additional requirements set out in the medical device regulations for Europe.
Indeed, the circumstances in which you can use self-declaration of conformity for UKCA marking are the same as for CE marking. If you were able to self-declare conformity for the CE marking, you will be able to do the same for the UKCA marking. As always, there are exceptions which prove the rule. An additional classification rule applicable to software for CE marking may require some manufacturers to engage with a notified body to continue to supply medical device software to Europe.
Nevertheless, much like GDPR, EU-based companies and UK importers will very likely experience increased administrative tasks, as well as possible additional complications caused by the fact that the CE mark will cease to be recognised. It is therefore essential that all involved parties are familiar with the new controls and procedures and stay updated on new developments following information from relevant authorities.
Overall, it is arguably a significant opportunity to design better regulatory processes specifically for the UK while offsetting medical device safety concerns for an improved healthcare future.
Finally, those companies which remain ahead of regulatory changes, including the vital shift to UKCA marking, will be best placed to consolidate their position through successful horizon scanning and potentially also seize a competitive advantage in the UK medical devices market over those that do not.
Having completed the consultation process at the end of 2021, publication of future legislation for UKCA marking is expected.
Whatever the case, now is the time to act and ensure compliance ahead of June 2023.