The world of healthcare and technology is undergoing a period of rapid transformation especially when it comes to evolving regulatory compliance requirements for medical devices.
Advancements in medical technology, ranging from AI to robotics, as well as the development and deployment of innovative devices, have brought forth immense opportunities for improving patient care and revolutionising the healthcare industry.
Meanwhile, regulators are responding to a growing need 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.
The rewards for businesses that face these challenges head on however are significant as the global medical devices market size was 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.
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.
The US medical device market
The U.S. medical device market, despite the FDA being traditionally seen as a particularly strict regulator, is an interesting starting point for medical device manufacturers as it was valued at USD 176.7 billion in 2020 according to Grandview Research, with imaging diagnostics and orthopaedics standing out as growth leaders.
While the route for a novel device – where the manufacturer is not able to demonstrate equivalence to an existing legally marketed device (a so-called ‘predicate’ device), may be perceived as particularly arduous, most medium risk devices typically require the submission of a 510k dossier.
This demonstrates that the device can be marketed is as safe and effective as a device already on the US market, and does not raise any new questions of safety and effectiveness.
Although the medical device manufacturer needs to ensure their QMS meets FDA requirements (currently 21 CFR Part 820), overall regulatory approval costs are also generally lower than in the EU for regulatory product assessment. Another requirement is the registration of company facilities and products.
If legally based outside of the USA, a US based Agent (21 CFR Part 807) is required and may act as an official correspondent with FDA.
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 in fact be restricted to that in the public domain and critical technical information can be hard to come by.
On a positive note, the FDA follows specific response timelines that favour planning and commercialisation objectives. Furthermore, demonstrating substantial equivalence via a 510(k) submission often does not require a clinical investigation, thus reducing time-to-market and overall costs.
The EU medical device market
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% , with in vitro diagnostics (IVD) representing the largest sub-sector of devices, followed by cardiology.
Compared with the 510(k), the journey towards approval for a medical device in the EU is quite complex and lengthy.
The evidence that the manufacturer needs to prepare to launch a medical device on the EU market is in fact generally 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 the company QMS, review technical documentation and assess clinical evidence.
Lately, there have been notable NB capacity concerns with the number of certified NBs climbing only slowly.
As a result, 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.
It is important to note, however, that the EU Commission has recognised 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 even existing medical devices.
As a result, several measures have now been 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.
The UK medical device market
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 NHS.
The NHS is perceived as 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 the UK is still operating a more mature regulatory system than the EU MDR, where UK risk classes and evidence requirements for certification 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, with the publication of The Medical Technology Strategy plan earlier in 2023.
This is a signal that the UK is open to embrace innovation, with 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 (UK 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.
Understanding the merits and drawbacks of the existing regulatory systems in major markets, however, can provide valuable context for the decision-making process.
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.
Timothy Bubb is Technical Director at IMed Consultancy
