Medtech regulation in 2021 and beyond: what's unfolded and what's to come
If necessity is the mother of invention, then crisis is perhaps its father, for some of the greatest human innovations have been sired in times of great distress.
Did you know that more people died from the 1918 flu pandemic, commonly known as the Spanish Flu than from World War I? The estimated 20 million deaths from the just-ended war, daunting as they were, paled in comparison to the estimated 50 to 100 million who lost their lives globally in the two-year-long pandemic that followed.
Devastating as it was, this flu was a remarkable commentary on hope because it was responsible for major healthcare advances such as centralized healthcare systems and employer-based insurance plans.
The COVID-19 pandemic is no exception, as it too has triggered its fair share of innovation. As 2021 goes out, riding on the pandemic’s 4th or 5th wave, depending on where you're reading from, let’s take a look at 3 examples of medical device regulatory frameworks and how they have been impacted by the pandemic.
1. The United States: Expediting Approval in Times of Emergency
The Food and Drug Administration (FDA) upholds rigorous science-based standards for the quality, safety, and effectiveness of new drugs and medical devices. The process can therefore be fairly lengthy. But in emergency situations, expedited approval is vital.
The regulator grants Emergency Use Authorization (EUA) during public health emergencies. EUA allows for the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases in emergency situations. This type of approval is issued under specific emergency conditions, such as when there are no adequate, approved, and available alternatives.
In the case of COVID-19 vaccines, for example, this was a no-brainer, in light of the speed with which the pandemic spread. Between December 2020 and February 2021, just one year after the pandemic outbreak, the FDA granted EUAs for three vaccines. In August 2021, the Pfizer-BioNTech COVID-19 vaccine received full approval. But it wasn’t just vaccines.
As early as March 2020, the FDA began granting EUAs for tests, drugs and devices needed to diagnose, treat, or prevent the spread of COVID-19, including COVID-19 tests, ventilators, respirators, face shields, and decontamination systems. The FDA has granted more than 600 EUAs during the pandemic period. These authorizations have taught us how efficient the regulatory process can be in an emergency and set the bar for regulators globally on how to balance stringency and flexibility when the situation requires it.
2. The European Union: Implementing MDR in the Midst of a Pandemic
The EU Medical Device Regulations (EU MDR) came into force on 26 May 2021 following a one-year extension due to the pandemic. Medical devices coming into the EU market from that date must conform to these new regulations. You can read a more detailed explainer of how the transition from the previous regulatory system works. As we start a new year, let’s look at what’s great about this new regulatory system, and a couple of speed bumps that are already affecting, or are likely to affect it.
Stricter requirements, especially in terms of clinical and post-market data, will result in eliminating unsafe and ineffective (in terms of performance) devices from the market.
Higher risk devices are given more scrutiny and must therefore meet a set of more stringent requirements.
In general, MDR places more scrutiny on device safety and performance, with way more general safety and performance requirements (23 sections), compared to MDD (14 sections).
The regulation is legally binding across the whole EU region.
EUDAMED. That’s the name of the electronic database of approved medical devices that the European Commission will maintain. And it’s not just a list—EUDAMED will include information such as manufacturers’, importers’ and distributors’ details, and clinical trial results. That’s a much higher level of transparency than ever before. Certain modules of this database will be accessible by the public free of charge.
With 100 articles more than its predecessor, the new regulation will stretch manufacturers much farther, demanding more time, effort and money to get to the market.
There aren’t enough certification bodies (also known as Notified Bodies) to certify companies under the new regulation
Most companies aren’t ready to transition to the new regulation, which puts them at risk of losing their certificates issued under the old directive
Besides forcing some of the current players to leave the market, there’s also a real risk that the more burdensome process could hinder innovation and discourage new players from entering the market.
What’s noteworthy is that the cons are all mostly growing pains. If the Notified Bodies and manufacturers can get through the implementation stages, EU MDR has great potential to serve the EU well.
3. Africa: Time is Ripe for a Unified Regulatory System
If Africa’s unified regulatory system doesn’t sound familiar, that’s because it’s still in the future for the continent—hopefully, the near future. Like the EU, a unified system of regulation could serve Africa well. Think of the benefits of a freer flow of devices in the African healthcare space. The current situation, where each country has its own system of regulation is cumbersome and inefficient. Medical devices are essential for diagnosis and treatment, so a delay in access to these devices is a delay to the provision of healthcare. A unified system will mean that, for instance, if a device is approved in one member country it will be approved in all of them, which is good news all around for manufacturers, healthcare providers and patients. Enhanced safety is also a big plus since a unified system can eliminate the sale of falsified devices, which are unsafe and ineffective.
The COVID-19 pandemic spurred the birth of an important development in Africa as well. Cape Town developer and manufacturer, Medical Diagnostech, produced Africa’s first-ever COVID-19 antigen test kit in 2021. The antigen test kit, which was approved by the South African Health Products Regulatory Authority (SAHPRA) in December 2021, gives results in 15 minutes.
This is a win in the fight against COVID-19, not just for South Africa, but potentially for the whole of Africa. For starters, it could provide a less costly testing option if it’s made available at a lower price than the imported tests. But it gets better. The South African developer plans to release this technology to African manufacturers. What a great prospect of the potential that Africa can achieve through collaboration, not just for medical technology, but also on a regulatory front.
And that’s where the real story lies for Africa—in the hope that the continent has the capacity to develop and manufacture medical devices. Medical devices developed and made by Africa for Africa, with the circumstances and resources of Africans in mind, have the potential to revolutionize healthcare for the continent’s patients. Local manufacturing is achievable. And an increase in manufacturing will lead to an increase in equitable access to quality healthcare facilities and services. But a unified regulatory system for medical devices is essential. Unfortunately, most African countries don’t have mature regulatory processes for medical devices.
The need for a legal framework
Since a large number of African countries do not have a legal basis for regulating medical devices, a unified system first and foremost requires political goodwill. Perhaps the most straightforward path is to have heads of state agree on and approve a memorandum of understanding. Then the legal process can find a foothold. While complex issues such as agreeing on a fair and practical fee system, and finding the resources for implementation require solutions, one thing is certain—Africa cannot continue to rely in perpetuity on clearance from the European and American regulators, whose processes are great for their own markets, but expensive and unsuited for the African market.
What have we learned?
The lessons from the past year for medical device regulation? Perhaps the ones that stand out most are that safety is key, that flexibility is necessary for emergencies, and that every market is unique. Global convergence is desirable and achievable through a collaborative and transparent approach. While we recognize that crisis can be the birthplace of innovation, may we not innovate as a result of crisis but in spite of it. May it not take another pandemic for us to realize the urgency of creating more sustainable and functional regulatory frameworks.