The U.S., EU, Or U.K.: Which Medical Device Market Should I Enter First?
By Leeanne Baker, Managing Director & Senior QA/RA Consultant, IMed Consultancy
Every medical device manufacturer planning to launch a new product faces the same dilemma: “Which market should we place the device on first?”
This is a time of major regulatory changes that aim to improve patient safety, ensure device effectiveness, and enforce ethical standards across all stages of the product life cycle. The new EU MDR/IVDR and the future U.K. Regulatory System pose several challenges to manufacturers looking to place a device onto these markets, as achieving regulatory compliance requires a deeper and wider understanding of the evolving regulatory landscape, as well as having precise planning, quality management systems, and effective risk assessment strategies in place. Despite this uncertainty, the sector was recently valued at $512.29 billion in 2022 and is projected to grow from $536.12 billion in 2023 to $799.67 billion by 2030, with a CAGR of 5.9% over the period.1
In this article, I focus on three of the major markets typically considered when you want to export your devices: the U.S., the EU, and the U.K.
A Brief Overview of The U.S. Market
The U.S. medical device manufacturers market size was valued at $176.7 billion in 2020 by Grandview Research 2. Despite the opportunities this market offers, manufacturers are usually hesitant to enter the U.S. market, due to the FDA’s reputation for being stricter than other regulators. While the bar may be high for very innovative, high-risk products, with the right support, choosing the right regulation pathway is the key to a swift market entry.
For example, while lower-risk devices require registration and listing with FDA, these are often exempt from formal regulatory submission to FDA prior to being placed in the U.S. market, while higher-risk devices are usually considered via a pre-market approval (PMA) route. On the other hand, the majority of medium-risk devices will typically require 510(k) registration. Other routes for novel devices are also available, such as the de novo submission and the Breakthrough Devices Program.3
Understanding the FDA’s procedural and cultural expectations is important for successful interaction as it operates in a completely different way than EU or U.K. authorities, with the FDA having a higher expectation of scientific understanding and basal regulatory competency during interactions, particularly for established manufacturers.
A Brief Overview Of The European Union Market
The European Union offers an almost equally large and attractive share of market for medical device manufacturers as the U.S. To enter the EU market, however, manufacturers need to build up a large body of evidence, create a technical file dossier and, for all but the lowest class devices, find a Notified Body to certify their products, evaluate their QMS, and review their technical documentation and, particularly, their clinical evidence. In addition to this, there are issues of linguistic fragmentation and regional legislative differences, leading more and more businesses to hesitate regarding EU market entry.
Despite this, it is also worth noting that although CE marking may take more time than FDA approval, the CE Mark is one of the certifications that is most widely accepted in other territories. The European Commission (EC) is addressing the current impedance to help make the EU a more attractive market, with various measures in the works to allow a smoother transition to the EU MDR/IVDR. Notified Body capacity issues also have been a deterrent to businesses as many NBs were not accepting new manufacturers or were requiring lengthy wait periods to begin the technical assessments needed for approval. Notified Body bandwidth is particularly taken up with the EU MDR transition, making it difficult for businesses wanting to propose product changes or reclassify devices and for businesses with new products to find a NB willing to take on their device. However, the EC has now taken new measures to relieve some of the pressure on Notified Bodies by reassessing the frequency of which they have to face reassessment by Competent Authorities.
A Brief Overview Of The United Kingdom Market
Although a smaller market, the U.K. is a key player in the health tech space with an appealing “one provider/one payer” model offered by the NHS.
In addition, the U.K. government is positioning the economy as an ideal breeding ground 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 U.K. economy, representing over half of all life sciences employment, with businesses situated across the U.K. and contributing billions of pounds to the economy. As a country we are known for world-leading scientific research and development capabilities, and the U.K. health and care system is globally recognized as a successful and trusted health system, making the U.K. a major player on the global healthcare stage.”4
From a regulatory perspective, the transition to the new U.K. MDR is in full swing with deadlines to meet new requirements following on from each other faster than many medical device manufacturers realize. Despite this, the U.K. is still operating a more mature regulatory system than the EU MDR, where risk classes are generally lower, especially for AI and software devices, as well as certain IVD products.
As a result, a growing number of AI and software-based device makers are expected to turn to the U.K. to find the ideal launch pad for innovation.
Considerations For Choosing Your First Market To Enter
When choosing the market you plan to enter first, manufacturers should evaluate each regulatory environment in addition to the scope for their product and general positioning and condition of the economy. From a regulatory perspective, the U.K. is currently awaiting publication of new medical device regulations, meaning it is crucial to stay up to date with and prepare for new deadlines and requirements. However, the U.K. is considering accepting other countries’ approvals to speed up admissions to accommodate the needs of manufacturers and tackle the challenges posed by the transition period.
Maturity of the device, therapeutic area, and classification are key factors to deciding where to launch a device, but overlooking regulatory aspects could have dire consequences if things do not go as planned, causing delays and additional costs. For example, selecting an inappropriate predicate device in the U.S., which can be successfully used in EU submissions. Or using an unsuitable device for equivalence in CE marking, which is considered equivalent and suitable under the different UK definitions. Similarly, products in the U.S. may have a higher or lower classification than the U.K. or EU, and in some cases, products may not even be regulated as medical devices due to differences in regulations between countries. Understanding the strengths and weaknesses of the regulatory systems currently active in these major markets, and the specific considerations for your medical device type can help frame the decision-making process.
This article is a summary of a full report on the topic. Access the full report here.
References
- Fortune Business Insights, The global medical devices market size was valued at $512.29 billion in 2022 & is projected to grow from $536.12 billion in 2023 to $799.67 billion by 2030, https://www.fortunebusinessinsights.com/industry-reports/medical-devices-market-100085
- Grandview Research, U.S. Medical Device Manufacturers Market Size, Share & Trends Analysis Report By Type (Diagnostic Imaging, Consumables, Patient Aids, Orthopedics), And Segment Forecasts, 2021 - 2028
- FDA website, https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
- Medical Technology Strategy Plan, February 2023, https://www.gov.uk/government/publications/medical-technology-strategy/medical-technology-strategy
About The Author:
Leeanne Baker is the founder and Managing Director of IMed Consultancy. As a regulatory and quality professional and senior consultant, she guides the team with her experience in global medical device regulation and quality projects, supported by a solid grounding in industry. She advises clients on how to demonstrate devices maintain suitable safety and that business processes are appropriately controlled, with a solid appreciation of the commercial implications of regulatory decisions.