Laura Friedl-Hirst, principal consultant and managing director, LFH Regulatory looks into accessing the UK market from a regulatory perspective and if it’s worth it.
LFH Regulatory
As a manufacturer have you thought about accessing the United Kingdom (UK) market but then decided against it? Understandably so, there have been complexities thrown into the mix with Brexit after the UK left the European Union (EU).
The medtech industry is one of Europe's most diverse and innovative sectors. But it also operates within one of the most tightly regulated environments worldwide. Driven both by complex regulatory changes and the quest for innovation, the medical device industry landscape is changing fast.
UK market share
Is it worth trying to access the UK market? Let’s start with the statistics.
Medtech Europe published data showing market share globally for 2022 and it is no surprise that the United States (US) had the biggest market share at 46.6%. The EU holds approximately 26.4% of the market share and UK holding approximately 10.1% of that shareholding.
It appears relatively low, however, today the UK proudly boasts the third largest medical device market in Europe, and the sixth largest worldwide with an annual turnover of approximately $33 billion (over £26 billion). The sector continues to experience rapid growth which is thanks to its single-provider and single-payer system, meaning the UK remains a hugely desirable market for medical device companies. With this in mind, it makes the UK an attractive market to enter but what are the regulatory requirements?
UK regulatory landscape
Since January 2021, the requirements for introducing medical devices to the market in Great Britain (England, Wales and Scotland) (GB) has undergone significant changes; notably, a new route to market and UKCA marking has been introduced for manufacturers seeking to bring medical devices to the GB market.
The UK Medical Devices Regulations 2002 (UK MDR) has been a crucial requirement within the UK’s regulatory framework since before Brexit. It closely aligns with and currently mirrors the requirements set forth in the following EU Directives;
- Medical Device Directive 93/42/EEC (MDD)
- Active Implantable Medical Device Directive 90/385/EEC (AIMDD)
- In Vitro Diagnostic Directive 98/97/EC (IVDD)
Since Brexit, Northern Ireland and GB have separated in terms of their regulatory requirements. Northern Ireland is now required to follow the current EU regulatory framework of the EU Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostics Regulation (IVDR) 2017/746, although it is governed by the same competent authority as Great Britain, the Medicines and Healthcare Product Regulatory Agency (MHRA).
Utilising CE marking for UK market entry
For already CE marked devices, it is worth noting there are transitional timeframes for manufacturers to transition to UKCA marking, enabling utilisation of their CE accreditation.
Class I/General IVD’s will not be accepted by the UK if their certification still falls under the EU Directives and are not required to be up classified under the EU MDR or IVDR to a higher risk device. In these cases, compliance with the EU MDR or IVDR will need to be claimed.
Taking advantage of these transitional timeframes with CE marked devices can help manufacturers enter the market with more ease until the UK framework is understood and ready to be implemented.
UKCA marking
It is well known that some devices have been up classified under the EU MDR/IVDR with the biggest impact on manufactures of class I being up revised to a higher classification and having to go through a review/accreditation process. If the device does not presently hold a CE mark, there are benefits of applying for UKCA accreditation even though the regulatory requirements are uncertain and are discussed below.
Class I/General (low risk)
Class I medical devices and general IVDs under the UK MDR are classified as low risk and are self-declared products that do not require assessment or approval prior to being put on the market.
As the UK is currently following UK MDR, products being up classified under the EU MDR/IVDR will not apply, hence there will be no review costs from Approved Bodies. The benefits are cost savings and time efficiency for market access giving an advantage for manufacturers who want quick market shares.
Although these devices are self-declared, manufacturers are required to make sure they are compliant to the UK MDR before release.
All other class devices
Class I sterile or measuring, IIa, IIb and III devices will be required to comply with the UK MDR. These device types will need to be reviewed by an Approved Body prior to market access and certified for the purposes of UKCA marking.
As of July 2024, there are nine UK Approved Bodies certified for UKCA accreditation for whom all vary under their certification capabilities. Approved Bodies are currently certified under the current UK MDR framework as the new UK regulatory requirements are pending further changes.
For current CE marked devices it is more efficient to access the UK market with this certification under the transitional timeframes posed under Figure 2 & 3 provided by the MHRA. Keeping closely up to date with the UK requirements to understand any updates or changes is a must and it is recommended to have a robust regulatory intelligence process.
Regardless of class, all device types must be registered with the MHRA prior to products being available on the market.
UK Responsible Person (UKRP)
The UK now requires any non-UK based manufacturers to appoint a sole UK Responsible Person (UKRP) to register all devices to access the GB market on the competent authority’s database prior to release.
If entering GB with a UKCA mark, there will be a need to affix the UKRP details onto the labelling is essential for importing devices onto the GB market.
Conclusion
As health systems search for innovative solutions to tackle disease and medical conditions, the industry is currently undergoing dynamic change and growth.
The UK’s medical device industry presents a valuable yet challenging landscape for manufacturers, characterised by opportunities for growth and success. Although there could be deemed to have complexities and uncertainty for accessing the UK market, the statistics certainly demonstrate a strong market as well as a thirst for innovation demonstrating.