A number of key changes to the UK’s regulation of the sale of medical devices took effect upon the UK’s exit from the EU. These changes have been on the horizon since the arrival of the new EU medical device regulations a number of years ago, and will continue to reshape the regulatory landscape for these products over the next few years.
For those operating in this market it is important to remember and consider the impact of these regulatory changes. For those considering entry into the UK market alongside the EU market, it is important to remember that the UK is now in effect a third country for European purposes – that is, it is a different market to the EU, and the ability to sell onto the EU market may not necessarily bring with it the ability to sell onto the UK market.
The UKRP and the EUAR
For manufacturers based outwith the UK and the EU, there has been a requirement for some time already to have an EU based authorised person (EUAR), acting as a point of contact for regulators, and holding technical and regulatory documentation. As the UK and EU are now separate markets, manufacturers will now need to appoint an authorised person in respect of the UK – the UK Responsible Person (UKRP).
The UKRP has a role which is more significant that the traditional EUAR role, and it is a role which carries with it certain key responsibilities. These responsibilities include the traditional ones – that is, acting as a contact for regulators and holding documentation – but they also now include roles such as ensuring that the devices have been placed upon the market are properly classified, that the documentation and certification held is full correct and complete, registration of themselves and devices with the MHRA, and in relation to vigilance and quality management.
Whilst some of these roles have arisen due to the general reshaping of medical devices sector regulation, some have also come as a result of the UK’s exit. As a result, manufacturers will need to consider and appoint a UKRP. Written proof of the UKRP’s status will also be required. This would commonly be captured in a long form UKRP agreement, executed by both the manufacturer and the UKRP.
What constitutes a medical device
More than ever, not least due to the current explosion in anti-Covid devices, it is important to consider whenever the product being made available is a medical device. The definition of a medical device was amended a number of years ago, to encompass more devices than were originally within scope when the UK regulations first came into force in 2002.
Device regulation in essence depends upon the nature and purpose of the device. This means a wide variety of devices may fall within the scope of the regulations – from data driven smart tracker devices such as body statistic monitors, to hospital furniture, alongside all the devices one may normally consider to fall within the scope of the regulations, such as surgical instruments, implantable devices and such like. Importantly, depending on the claims, purpose and manner of use, PPE can fall within the scope of the regulations.
One should not also forget the other product safety regulations which may apply depending on the circumstances, such as those relating to protective equipment, electromagnetic compliance, consumer claims and such like. Often, even if the medical devices regulations do not apply, similar compliance obligations will require to be fulfilled by manufacturers through the impact of other safety regulation.
A UK / EU place of business
Where use of a UKRP is obliged, that UKRP will need to be based physically in the UK. Similarly, where a manufacturer is selling onto the EU market, its EUAR will need to be physically based in the EU. UKRPs and EUARs are not recognised as equivalent by either jurisdiction, as such non UK / EU manufacturers will need to have separate representatives for each market.
This will also be the case for manufacturers based in each market – an EU manufacturer will need to have a UKRP, and a UK manufacturer an EUAR. For those that have not prepared for this eventuality, or whom do not already have places of business in the relevant jurisdiction, this is a significant change. Whilst there are solutions which can be implemented, they will require an element of restructuring. It may be something that manufacturers have already addressed, due to data compliance requirements, that is the obligation to have an EU representative for GDPR purposes where EU patient data is being processed.
Importers and distributors
Importers and distributors into the UK will now see a much increased role. With that greater role will come greater liability and greater risks. Therefore, it will be important for persons acting in that capacity to ensure that they are properly compliant, and also properly protected under their supply contracts with manufacturers. The latter may be something which they have already addressed, due to changes in other areas, such as tax, currency fluctuation, customs clearance and such like, but if not it is important that contracts are revisited to ensure they are both workable and adequate.
Sitting behind much of the regulation is the need for device certification. Whilst less risky / lower class devices remain able to be self-certified, where greater risks are involved than notified bodies will need to be involved. In a number of situations notified body certification by an EU based notified body will not be sufficient for UK purposes, and a UK based notified body not suitable for EU purposes.
This is a complex area in current regulation, and manufacturers, and also UKRPs, EUARs, importers and distributors, will need to be cognisant of what needs to be done in relation to a particular product, particularly in that product is not already available upon the relevant market. Certification feeds into a number of area, including device registration with local market authorities, but also importantly product packaging and labelling.
Packaging and labelling
Selling onto the UK market will now require different packaging and labelling to be implemented. Whilst there are some transitional provisions relating to products already on sale, new products will largely require UK compliant labels. These labels will need to reflect the UKCA rather than the EU CE mark. They will also need to reflect the UK certification regime.
Where products are imported into the UK, they will need to be over-labelled. There are some important provisions of the regulations relating to that over-labelling, its position, and the information that it needs to contain. Over-labelling approaches will also need to be cognisant of underlying contractual supply arrangements, and the provisions of trade mark law and consumer protection law, in relation to that over-labelling.
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