In the dynamic world of medical device innovation, the path to market often has regulatory hurdles. Recently, these changes have been amplified in the European Union (EU) due to the implementation of the new Medical Device Regulation (MDR). This has led medical device companies, particularly those based in the United States, to reconsider their market entry strategies. One emerging trend is a shift towards a UK-first approach. In this article, we delve deeper into the reasons behind this trend and the benefits of working with a UK-based company like Europlaz brings.
The EU’s MDR: A regulatory challenge
The EU’s MDR, which came into force in 2021, has introduced new criteria for obtaining the CE mark, a mandatory certification for medical devices to be marketed in Europe. While the regulation aims to enhance patient safety and ensure the highest quality of medical devices, its implementation has resulted in a significant backlog of certifications. This has left many companies, especially innovative healthcare and biotech start-ups, in a state of limbo.
The certification delays are not just a minor inconvenience. They have serious implications for these start-ups, often necessitating additional funding rounds to sustain operations during the extended waiting period. In some cases, the delays have even compelled companies to reassess their entire business strategy, with many contemplating initial rollouts in markets with more streamlined certification processes.
The UK: An attractive alternative
This is where the UK comes into the picture. Despite the complexities of Brexit, the UK presents an attractive alternative for medical device companies seeking a more efficient route to European markets. With the NHS as a central customer, along with private healthcare driving innovation, the UK medical industry is constantly looking for new ways to help patients. This proactive approach positions the UK as an ideal market for novel and niche products.
The benefits of the UK market
One of the advantages of the UK medical device market is its “one provider, one payer model”. The National Health Service (NHS) tenders every four years, increasing the chances of successfully positioning medical devices within its framework. This is in stark contrast to many European countries where purchasing decisions are made at a regional level.
Another significant benefit is the absence of language barriers. Unlike Europe, where each country requires ad hoc translation and localisation of instructions for use, technical documents, and even advertising, the UK requires minimal changes. This can save companies considerable time and resources, further speeding up the market entry process.
Navigating the UK regulatory landscape
However, to successfully navigate the UK market, businesses need to familiarise themselves with key regulatory entities and roles, specifically the Medicines and Healthcare Products Regulatory Agency (MHRA) and the UK Responsible Person (UKRP).
The MHRA is the entity responsible for regulating the UK medical devices market, performing market surveillance and making decisions regarding the marketing and supply of devices in the UK.
The UKRP, on the other hand, acts on behalf of businesses based outside the UK to carry out all tasks needed to successfully place their device on the UK market. This includes liaising with entities such as the MHRA, ensuring the declaration of conformity and all technical documentation have been drawn up, and keeping a copy of all relevant documentation on hand. The right UKRP can make a significant difference when it comes to placing and maintaining a new medical device on the market.
The Windsor Agreement and where we are now
To ease this process the Windsor Agreement was introduced in February 2023. This measure is designed to address trade concerns with Northern Ireland. This simple agreement set up ‘red’ and ‘green’ customs lanes with fewer checks for goods between Great Britain and Northern Ireland (green lane) while the red lane is used for goods that are destined for the Republic of Ireland and beyond.
For the medical sector, there are no specific mentions of medical devices, these new procedures may go a long way to speeding up goods moving across borders and simplify the process.
Additionally, for medicine this may mean:
- The European Commission will omit certain EU rules for medicinal products intended for the NI market.
- The MHRA will oversee and grant permissions for all medicines in NI following UK regulations.
- Medicines can be imported from GB to NI without requiring a manufacturing import permit.
- The EU’s Falsified Medicines Directive about safety and tracking won’t be applied in NI.
- Medicines will need a “UK-only” label.
- Products available when the changes take effect can stay on the market.
- These modifications will be effective from 1 January 2025.
As ever it’s important to keep up to date with the latest developments from the MHRA and adhere to regulatory requirements. The Windsor Agreement is a step in the right direction to reduce barriers to entry but there is still room for improvement.
Europlaz: The strategic advantage of a UK-first approach
In conclusion, while the EU’s MDR has created a challenging environment for medical device companies, it has also opened up opportunities for alternative market entry strategies. The UK, with its streamlined regulations, supportive medtech strategy, and simplified language requirements, offers a compelling option for companies seeking a more efficient route to market.
By partnering with the right UKRP and medical device manufacturer (such as Europlaz), you can navigate the regulatory landscape with ease, and bring innovative medical devices and products to patients more quickly and efficiently.
The UK-first approach not only offers a strategic advantage in the current regulatory climate but also positions companies for success in a market that is actively seeking and supporting medical technology innovation.
If you’d like to know more about our experience, some of the projects we’ve worked on, or how we can help you bring your medical device design to life contact us today. Our team is on hand to provide a fully-bespoke system tailored to your needs.