Pharmaceutical Market Europe • May 2024 • 41-43
MEDICAL DEVICES
Medical devices – the rapidly evolving landscape of healthcare and technology
How choosing market entry in one country over another can impact the success of your medical device
By Tim Bubb
When in the early stages of developing a medical device and planning for commercialisation, one of the most important aspects to consider is which market to enter first.
Considerations regarding market size, need for that specific device, the general medical landscape that it will be entering, the procurement processes used by major buyers whether these are national or private, are key to ensuring that it has a successful start and that it generates revenue to invest back into the business. One key element that too many businesses overlook is the impact that the regulatory pathways offered by each country will have on the launch, both in terms of timing and expenses.
In today’s rapidly evolving landscape of healthcare and technology, navigating the realm of regulatory compliance for medical devices has become an increasingly complex endeavour. With advancements in medical technology, the development and deployment of innovative devices, and the unprecedented regulatory shake-ups – in the form of the introduction of the new EU MDR and IVDR and the Future UK Regulatory System in major markets such as Europe and the UK – the scenario is difficult to navigate.
Manufacturers and stakeholders must navigate through a web of complex standards, guidelines and country-specific regulations before they decide which markets will be the most profitable to enter and which ones they should tackle first, laying the groundworks for future success. While the global medical devices market size was valued at $512.29bn in 2022 and is projected to grow from $536.12bn in 2023 to $799.67bn by 2030, with a CAGR of 5.9% over the period, this article focuses specifically on the three of the most popular markets – the EU, the UK and the USA – highlighting some key considerations relating to entering each of these geographies ‘first’.
EU medical devices market
The introduction of the new EU MDR, with its staged roll-out and series of delays to ensure suitable provisioning, has combined with the effects of Brexit, effectively drawing the UK out of the European regulatory environment to impose the creation of yet another set of guidelines and regulations.
After a series of extensions, the Medical Devices Regulation (EU) 2017/745 (MDR) implementation is now set to come into force at the end of 2027 for high-risk devices and at the end of 2028 for medium- and certain lower-risk devices.
Although manufacturers should be aware that full compliance requirements for some products may be delayed in the EU, a number of key elements of regulation have already been enforceable for a while. Specifically, PMS requirements under the MDR that have been applicable since 26 May 2021 for all medical devices sold in the EU, regardless of a device’s MDR CE Marking status. Proactive PMS measures have been a requirement for IVDs since 26 May 2022.
Understandably, medical device manufacturers have embraced extensions, particularly as Notified Bodies are also under significant capacity pressure, but have also become somewhat confused as to which requirements are already enforceable and which they have more time to prepare for.
In the EU a medical device manufacturer of medium-risk devices faces quite a complex and long journey towards approval, needs to build up a larger body of evidence and create a technical file dossier. It also needs to find a Notified Body to certify its products, evaluate its QMS, review its technical documentation and particularly its clinical evidence.
‘The FDA operates with very different regulations and systems to EU authorities, so understanding of FDA procedural and cultural expectations is important for successful interaction’
Risk class of the device is a major determinant of how much investment of time and resources will be required to get the product onto the market. In addition to linguistic fragmentation that raises costs for labelling and marketing materials, there are also regional legislative differences within each country.
On a more positive note, the EU Commission is working on making the EU a more attractive market and to ensure that patients are not put at risk by a lack of new, innovative and existing medical devices. Extensions of deadlines for implementation for existing products certified to older regulations is one such measure.
Finally, although CE marking may require a larger engagement, the CE mark is one of the certifications that is most widely accepted in other territories and therefore ideal for manufacturers that want to scale up and export their products globally.
US medical devices market
For the majority of medium-risk devices, the typical regulatory route is the submission of a 510(k) registration. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective as an already legally marketed device.
Lower-risk devices require registration and listing with FDA, but are often exempt from formal regulatory submission to FDA prior to being placed in the US market. Higher-risk devices, on the other hand, are usually considered via a pre-market approval (PMA) route, which is similar in approach and evidence requirements to UK and EU Class III medical device certification.
A route for novel devices also exists, where the product is not able to demonstrate appropriate similarity to an existing legally marketed device, which is called a De Novo submission.
If there is an equivalent device with the same intended use and similar technology, submission is vastly simplified and, while the device developer needs to ensure its QMS meets FDA requirements (21 CFR Part 820), regulatory approval fees are fairly low. A clinical investigation isn’t always necessary when using the 510(k) submission route, helping to reduce time-to-market and overall costs.
The manufacturer must use its development documentation to support its argument of substantial equivalence when writing the 510(k), which needs to be carried out in line with publicly available FDA guidance. If this is its own device, it will have access to all the information about the candidate, but if this is another manufacturer’s device it is unlikely there will be access to technical information. The device manufacturer will also need to undertake establishment registration and, for non-US (foreign) manufacturers, arrange a US Agent to act as a US-based contact for the manufacturer (21 CFR Part 807).
The FDA operates with very different regulations and systems from EU authorities, so understanding of FDA procedural and cultural expectations is important for successful interaction. While manufacturers who successfully find a suitable candidate will have a reasonably straightforward pathway, innovative devices may need to follow the more complex De Novo process.
UK medical devices market
The current UK medical device system is based on the older European Union medical device directive and new regulations are being gradually implemented. Some differing requirements, such as the need to have a UK Responsible Person if a manufacturer is based outside the United Kingdom have been in force as of January 2021. New regulations on post-market surveillance have been drafted and a new regulatory system is expected to be published in 2025.
‘New UK regulations on post-market surveillance have been drafted and a new regulatory system is expected to be published in 2025’
While a smaller market than the overall EU and US, the UK is significant player in the global medical device market and is increasingly positioning itself as an ideal market for products that are novel and niche. As published in the first ever Medical Technology Strategy plan in February 2023: ‘MedTech is a vitally important industry for the UK economy, representing over half of all life sciences employment, with businesses situated across the UK and contributing billions of pounds to the economy. As a country we are known for world-leading scientific research and development capabilities, and the UK health and care system is globally recognised as a successful and trusted health system, making the UK a major player on the global healthcare stage.’
From a regulatory perspective, the transition to the new UK MDR is in full swing with deadlines to meet new requirements following on from each other faster than many medical device manufacturers may realise. Currently, however, the UK is still operating an established regulatory system, where risk classes are generally lower than in the EU, especially for AI and software devices, as well as certain IVD products.
For businesses placing devices on the Northern Ireland market, where the EU MDR and EU IVDR have applied in Northern Ireland respectively since May 2021 and May 2022, there are several options for Northern Ireland compliance using either the UK or EU regulatory systems.
While there is no single answer to the conundrum: ‘which market should I enter first?’, understanding the impact of regulatory pathways and scenarios of the success of a market entry is key. Overlooking the impact of regulatory issues could cause delays and drive manufacturers to incur unexpected costs at a time when successful launch is critical to putting their best foot forward onto the market.
References are available on request.
Tim Bubb is Technical Director at IMed Consultancy
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