Leeanne BakerManaging Director and Quality & Regulatory ConsultantIMed Consultancy
The world of healthcare and technology are undergoing a period of rapid transformation especially when it comes to evolving regulatory compliance requirements for medical devices. On one hand advancements in medical technology, ranging from AI to robotics, and on the other the development and deployment of innovative devices, have brought forth immense opportunities for improving patient care and revolutionizing the healthcare industry. As we have seen, global regulators are responding to a growing need to improve patient safety. All these regulations in fact aim to safeguard patient safety, ensure device effectiveness, and maintain ethical standards throughout the product lifecycle, from design and manufacturing to post-market surveillance (PMS). As a result, achieving regulatory compliance for medical devices has become increasingly complex.
Europe and the UK, for example, are experiencing unprecedented regulatory shake-ups in the form of the introduction of the new EU MDR and IVDR and the Future UK Regulatory System. To add to this climate of uncertainty there have been various extensions for Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) implementation, which medical device manufacturers have had to keep on top of.
The rewards for businesses that face these challenges head on however are significant as the global medical devices market size was valued at $512.29B in 2022 and is projected to grow from $536.12B in 2023 to $799.67B by 2030, with a CAGR of 5.9% over the period.1 Only a deep understanding of the changing regulatory landscape, meticulous planning, robust quality management systems, and effective risk assessment strategies can help manufacturers truly get to grips with complex standards, guidelines and national regulations to ensure seamless market entry or expansion into new territories.
Opportunities and Risks of Launching in the US First
At first glance, the U.S. medical device market immediately reveals two opposing poles: on the one hand the FDA is traditionally seen as a particularly strict regulator, on the other the market size of the US is enough to whet any medical device manufacturer’s appetite.
The US market was in fact valued at USD $176.7B in 2020 according to Grandview Research, with imaging diagnostics and orthopaedics leading the fray.2
While the route for a novel device, where the manufacturer is not able to demonstrate similarity to an existing legally marketed device, may indeed be deservedly perceived as particularly arduous, the majority of medium-risk devices typically require the submission of a 510(k) registration. This 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 therefore not raising any questions on safety and effectiveness. The result is that products for which an equivalent device with the same intended use can be found are relatively simple to place on the market in the US.
Although the medical device manufacturer needs to ensure their QMS meets FDA requirements (21 CFR Part 820), overall regulatory approval fees are also generally seen as lower than in the EU for product assessment. Another requirement is the establishment of registration and finding a US Agent (21 CFR Part 807).
As we move into the cons of entering the US market first, even though the process is simpler and cost-effective when a predicate can be found, the latter is not always an easy task. Gaining access to all the information about the predicate, when this has been manufactured by another company, may prove difficult. Information will be restricted to that in the public domain (e.g., the equivalent device 510(k) summary, manufacturer websites, publications, IFU, brochures and public complaints data and critical technical information will be hard to come by. In addition to this drawback, the manufacturer must accurately prove the device’s substantial equivalence when preparing the 510(k) submission, in accordance with the publicly available FDA guidelines. To do this they should rely on their development documentation.
On a positive note, the manufacturer can expect the FDA to follow specific response timelines that favor planning and commercialization objectives. Furthermore, demonstrating substantial equivalence via the 510(k) submission can sometimes obviate the need for a clinical investigation, thus reducing time-to-market and overall costs. A favorable outcome will result in the manufacturer receiving a confirmation letter, affirming the device’s substantial equivalence. Conversely, if the manufacturer receives a Not Substantially Equivalent (NSE) letter, they must initiate the process anew, either by identifying a new predicate device or exploring an alternative submission type.
Understanding the FDA’s procedural and cultural expectations is vital for successful engagement. While manufacturers with a suitable predicate experience a relatively straightforward approval process, innovative devices might need to navigate a more intricate path, known as De Novo. In cases where a manufacturer is unable to identify a suitable predicate, it may indicate that there are currently no similar devices cleared in the US market. Alternatively, similar devices might exist, but the search terms used failed to yield pertinent results. Before embarking on a more intricate and costly submission route, manufacturers should consider seeking the guidance of an expert consultant who can aid them in the search for a suitable predicate device and explore available market access options in the USA.
Opting for EU Market Entry as a First Route
While the US is the biggest world market with 43.5% share of medical device sales, the European Union trade bloc follows closely with 24.5%.3 Its largest five markets, Germany, France, the United Kingdom, Italy, and Spain offer solutions for many disease areas with in vitro diagnostics (IVD) representing the largest sub-sector of devices, followed by cardiology. The clinical need the medical device is addressing and whether it is relevant to the target geography is in fact a key element in evaluating the potential of a target first market for product launch.
Compared with the 510(k), the journey towards approval for a medical device in the EU is quite complex and lengthy. The body of evidence that the manufacturer needs to prepare to launch a medical device on the EU market is in fact much more extensive and needs to be supported by the creation of a technical file dossier. In addition to this, it is necessary to engage with a Notified Body (NB) to certify the device, evaluate their QMS, review their technical documentation and assess their clinical evidence.
There have been notable NB capacity concerns with the number of certified NBs climbing slowly and risking a significant slow-down. In October 2022 the 38 existing Notified Bodies had issued 1,990 of the 8,120 applications received according to BSI, leaving a worrying majority of devices still to transition to the EU MDR by May 26, 2024.4
Many NBs are not accepting new manufacturers, or requiring lengthy pre-assessment wait periods to begin the technical assessments needed for approval impacting the time to market of products and, critically, access to sometimes life-saving devices for patients. In particular, NB bandwidth is occupied with this transition making it difficult for businesses wanting to propose new, innovative products or more simply to make product changes or reclassify devices to find an NB willing to take them on.
Like elsewhere, in the EU the device’s risk classification plays a pivotal role in determining the financial resources, workforce, and time required to bring a product to market. However, due to the prevailing uncertainties and the limited capacity of Notified Bodies (NB), an increasing number of businesses are opting to either abstain from or postpone entering the European Union market.
Furthermore, aside from the linguistic diversity that entails investments in specific labelling and marketing material translations for each country, there are also variations in regional regulations that need to be taken into consideration. For instance, Germany enforces stringent regulations on medical device pricing. Pricing decisions may also be influenced by regional, provincial, and other governing bodies, depending on where the medical device will be sold.
It is important to note, however, that the EU Commission has recognized the existing issues and is actively working to enhance the appeal of the EU market and safeguard patients from potential risks associated with a shortage of new, innovative, and existing medical devices. As a result, several measures are being developed to simplify the transition from earlier regulations to the EU MDR/IVDR. One of these measures involves extending deadlines for the implementation of new regulations, which eases the burden on products already certified under older regulations.
Simultaneously, the availability of the EUDAMED database is providing businesses and the public with greater access to information, promoting innovation. However, this accessibility also means that competitors can access more data related to manufacturers’ devices.
It is important to note that while obtaining CE Marking may be more time-consuming and slightly more complex, it remains one of the most widely recognized certifications in the world. It often holds more weight than FDA approval and is especially effective in expediting market entry in regions such as the Middle East, Africa, and former Commonwealth nations. Therefore, manufacturers looking to expand rapidly and export their products globally would be wise to consider obtaining EU certification before pursuing other certifications.
The Promise of the UK: A Fast-Track for Innovation
The UK’s medical device market may be smaller in comparison to the broader EU and US ones, yet it still holds a significant position on the global stage. This is due not only to the absence of substantial language barriers for US manufacturers and many other global producers who have adopted English as the universal language of business, but also to the appeal of the National Health Service (NHS). The NHS is perceived as presenting a “one provider/one payer” model, and its four-year tender framework provides ample opportunities for manufacturers aiming to engage with a single, major buyer.
Currently, however, the UK 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. Moreover, the UK is increasingly establishing itself as an attractive market for innovative and specialized products. This is in direct contrast to the EU, where Notified Bodies are under strain and are hesitant to take on new products, and to the US, where the approval pathways for innovative and high-risk products tend to be more intricate. The Medical Technology Strategy plan published in February 2023 highlights this new tole: “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.”5
This environment is a fertile breeding ground for innovation, especially for emerging medical device manufacturers. Notably, there’s a strong emphasis on innovative software devices, which have climbed the regulatory priority ladder, opening up the possibility of novel, swifter routes to market.
On the regulatory front, the shift to the new UK Medical Device Regulation (MDR) is in full motion, and the pace at which new requirements are emerging may catch many medical device manufacturers off guard. To accommodate the diverse requirements of advancing cutting-edge technologies, the UK is also exploring the recognition of approvals from other countries to expedite market access.
For medical device manufacturers contemplating their initial market entry, there isn’t of course a single straightforward answer. However, fully grasping the merits and drawbacks of the existing regulatory systems in major markets can provide valuable context for the decision-making process. Undoubtedly, factors like device maturity, therapeutic domain, and classification will influence the choice of the market with the highest potential for success. Nevertheless, embarking on this journey without the guidance and expertise of experienced professionals can entail unwarranted risks, especially within today’s dynamic and intricate regulatory environment.
Enlisting the support of international regulatory specialists not only aids in navigating the intricacies of specific markets, efficiently managing the expectations of regulatory authorities, but also facilitates the identification of commonalities among the regulatory requirements of different regions. This, in turn, assists in structuring a well-informed and strategic market entry approach.
References
1. 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
2. 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, https://www.grandviewresearch.com/industry- analysis/us-medical-device-manufacturers-market
3. MedTech Europe, The European Medical Technology in Figures, Market (Last update 19.09.2022) https://www.medtecheurope.org/datahub/market/
4. BSI, Will the EU Medical Devices Regulations certificate cliff edge in 2024 be avoided? https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/will-the-eu-medical- devices-regulations-certificate-cliff-edge-in-2024-be-avoided/
5. Medical Technology Strategy Plan, February 2023, https://www.gov.uk/government/ publications/medical-technology-strategy/medical-technology-strategy
Author Biography
Leeanne Baker, the founder of IMed Consultancy, guides the team with her extensive experience in Global Medical Device Regulation and Quality projects, supported by a solid grounding in industry. A highly regarded Regulatory and Quality professional and Senior Consultant, Leeanne can also relate to business challenges bringing a solid commercial understanding to the process of launching a medical device into a new market.
Publication Detail
This article appeared in American Pharmaceutical Review:
Vol. 26, No. 8
Nov/Dec 2023
Pages: 55-57
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