The rapidly evolving landscape of MedTech trials

Over the years we have seen significant updates to regulations and guidance across the medical devices, in vitro diagnostic and pharmaceutical sectors.

It is clearly well recognised that through the industry’s innovation in science and technology, the sectors have been evolving at an exponential rate.

The regulators have been embracing these innovations and developing and adapting regulatory frameworks to ensure safety, efficacy, transparency and traceability of drugs and devices on the market.

Indeed, we are seeing some very noteworthy changes that are shifting the regulatory landscape in MedTech.

The regulatory environment for MedTech has been evolving in a number of different ways, but there are a few initiatives from regulators that are particularly significant.

EU Medical Device Regulation (MDR), building upon the previous Medical Device Directive 93/42/EEC (MDD), was adopted and implemented as of May 2021, and has an increased emphasis on device safety.

While the implementation of the regulations has been delayed to ensure an orderly transition following the impact of COVID-19, MDR has had a significant impact on the landscape for the operations of medical device manufacturers, importers, distributors and health institutions, and generally economic operators.

As an incredibly stringent set of regulations, there are many aspects to MDR, but among its key measures are enhanced vigilance and market surveillance, data traceability, and a risk-based approach to device classification (ranging from low-risk class I, medium to high-risk class IIa, IIb and high-risk class III).

Non-compliance can result in the suspension or revocation of conformity certificates, and manufacturers must meet several obligations, including registering with notified bodies and the European Database on Medical Devices (EUDAMED).

EUDAMED, which will go a long way to improving the transparency and traceability of products, provides a centralised European database for the data management of information on medical devices.

This will facilitate the communication of both pre- and post-approval product information between economic operators, the Commission, EU member states and, in some cases, healthcare professionals and the public.

The outcome is the ability to track and trace specific products and, where necessary, conduct local recalls more quickly and easily. Although there are a number of modules available the European Commission has postponed the implementation of the system multiple times, and the new target date for full functionality is now Q2 2027.

The obligation to register devices with notified bodies has posed a particular challenge. Notified bodies in different countries across the EU needed to be audited to ensure that they would all use the same quality standards.

While this was a necessary step to ensure the best possible outcomes for patients, it did cause a backlog as companies waited for the completion of that audit before being able to register their products in certain countries – increasing delays and costs for MedTech companies.

The challenge for smaller MedTech companies is finding the resources required for clinical trials to produce the level of data needed to meet EUDAMED standards.

Med device organisations have been preparing for this transition and there have been significant costs of this compliance for many years.

Despite the challenges of compliance (and time will tell how well companies have adapted to the changes), MDR provides far greater clarity and helps to ensure that patients can be confident in the safety of their products.

The UK played a significant role in consulting on and developing MDR, but due to Brexit, the MHRA has carved out its own regulations, which, after public consultations, are currently in the process of being implemented.

In the immediate term, the UK has issued a draft policy to facilitate recognition of international regulators’ approvals of medical devices, with recognition of EU approvals to potentially continue until 30 June 2030.

For the most part, these follow the same principles as the MDR with the intention to increase transparency and improve patient safety.

Indeed, one of the five pillars upon which the roadmap is built is that the regulation will be ‘proportionate’, supporting businesses through access routes that build on synergies with both EU and wider global standards. Its other pillars include:

• •Strengthening MHRA power to act to keep patients safe
• Making the UK a focus for innovation, the best place to develop and introduce innovative medical devices
• Addressing health inequalities and mitigating biases throughout medical device product life cycles
• Setting world leading standards – building the UKCA mark as a global exemplar.

The UK government is now ensuring that it engages fully with industry stakeholders to ensure that any regulatory plans in MedTech will work on a practical level.

Good Clinical Practice guidelines were first adopted in 1996. Technology has advanced at such a rate over the last 30 years, that the technologies that patients benefit from today are almost unrecognisable.

For example, pacemakers can transmit data directly to your phone. But at the other end of the spectrum, these technologies can also be exploited and hacked.

As such, the ICH has worked alongside industry to create clearer, modern guidelines that are fit for purpose, known as the ICH R3 guidelines.

Part of the aim of these changes is to be able to remain relevant as technology continues to evolve.

The guidelines reflect the direction of modern clinical trials, including details on how to manage decentralised clinical trials (which make trials much more convenient for patients) and managing data life cycles.

The industry has had to deal with some teething problems arising from these new directives, with some saying that the costs of compliance would come at the expense of innovation.

Others have had to wait for the backlogs to clear because of MDR. Some companies have divested products as they tried to accommodate these developments.

However, the biggest MedTech firms have the resources to support the changes, and growing companies will be able to make sure that their policies align with regulations from the get-go.

The current direction of travel in MedTech regulation is promising better outcomes for patients and greater clarity on expectations for MedTech companies.

Credit should go to regulators in Europe because they have sought (and continue to seek) constructive dialogue with the industry to make informed, robust regulation to meet the challenges of the modern world.

There will undoubtedly be more changes into the future. While the latest regulations are aiming to be future-proof, the emergence of AI is further shifting the regulatory landscape.

For instance, we have already seen the EU propose its AI Act. As an industry, we are working to establish where this Act sits alongside existing regulation.

Indeed, the European Medicines Agency has been engaging closely with key stakeholders with numerous workshops to develop its own guidance.

While there are no clear conclusions yet, suggestions from its reflection paper on AI last year indicate that regulation should support the use of AI in life sciences but that a human-centric approach should guide its development and deployment.

The conversation will continue to evolve – but I am confident that regulators will continue to address the challenge.

Fiona Maini, Senior Director, Global Compliance and Strategy at Medidata. Go to medidata.com