Fiona Maini, compliance & strategy principal at Medidata, discusses the impact of COVID-19, new EU regulations and Brexit, as well as its impact on the medical device and IVD marketplace.
2020 was a difficult year for medical device and in vitro diagnostics (IVD) companies, with 2021 continuing to pose challenges. A trifecta of issues – new regulations; the COVID-19 pandemic; and geopolitical circumstances (for example Brexit) – have combined to create a ‘perfect storm’ environment. But with challenges comes opportunity for positive change.
New regulations requiring a modified operational model
Whilst companies have been preparing for the European Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) for some time, 2020 was when these new regulations, which set out safety and quality requirements for manufacturers and suppliers of medical devices, were due to come into force. Although medical device companies were given a brief reprieve after the pandemic delayed the introduction of MDR, the same was not true for IVD companies, who must now comply with almost pharmaceutical-grade regulation. IVDs, clinical tests conducted outside of the body on samples such as blood and tissue, are used to determine the disease state with a view to curing, mitigating, treating, or preventing a condition. Prior to the implementation of IVDR, IVDs were fairly loosely regulated, with around 15% having to go through regulated bodies. Now, that figure stands closer to 85%.
The change resulted in a large number of products having to go through the regulatory process, raising the question of whether such stringent regulation is strictly necessary for IVDs, or whether a lighter version could have been implemented. Whilst the introduction of the MDR was an obvious next step following several industry disasters, IVDs have not had such issues and are far less invasive. However, it is important to remember that getting the wrong measurement from an IVD can greatly impact a patient’s treatment, and the regulations give patients greater transparency.
IVDR represents a big step up for IVD companies, who are now required to implement systems and procedures that they are unlikely to have had before. This means changing their operating model to become more open and transparent, which is no small task. Companies that have had a product on the market for years will now also need to comply with the regulation, with many struggling to integrate and align the required data sets. Consequently, companies are having to create data that hasn’t previously existed or obtain data from various different siloes, whilst medical device companies are also having to ensure that they have more information retained and ready for inspection. This is a resource-intensive process, meaning that companies who do not have the resources to produce or obtain the required data could ultimately decide to take their products off the market.
These challenges will impact many start-ups, who will find it difficult to get a product to market, paving the way for greater consolidation, which could have the potential to stifle innovation. It’s worth noting that, as stated by the Medicines and Healthcare products Regulatory Agency (MHRA), “the provisions contained within the EU MDR and EU IVDR will not be transposed into law in Great Britain and will not be implemented in Great Britain.”
Geopolitical circumstances
Another anticipated, but still significant, regulatory change is the implementation of new rules following Brexit. Overall, the UK has been pretty well-prepared for the changes, although there have been some inevitable teething problems. It goes without saying that Brexit has resulted in a range of additional costs and considerations for medical device companies, with more paperwork and more resources required. There remains considerable uncertainty surrounding the near- and long-term impacts of Brexit, particularly surrounding supply chains, manufacturing costs and processes, and taxation implications.
One of the most significant impacts of Brexit is on supply chains. All of the components that make up one medical device may come from different places, which may present a number of issues, particularly regarding resources and costs. The process now also entails additional steps, such as the requirement for a ‘qualified person’ in both the UK and the EU to accept a product. Prior to Brexit, only one ‘qualified person’ was required to deliver a product from the UK to the EU, whereas now a ‘qualified person’ is needed in both due to the UK’s ‘third country’ status.
However, a potential outcome of Brexit is the MHRA’s, increased independence and the ability to react with agility, coupled with a mission to collaborate on a global scale. As a separate body, it can implement its own medical devices laws separate to MDR and IVDR. As a result, it has developed an open-door policy within its innovation function, which will hugely benefit the sector. Over time, the MHRA could become a body similar to the US Food and Drug Administration (FDA), with increased pragmatism and flexibility.
The COVID-19 pandemic
Finally, the biggest challenge of the past year facing not just the medical device industry, but the entire world, was the COVID-19 pandemic. Since the first lockdown, many trials have been halted or unable to start. Whilst some companies were able to mitigate this challenge through the use of technology and virtual trials, many trials require in-person visits and were unable to resume.
The pandemic has also impacted lead times of notified bodies, which was a particular problem in the early stages of the pandemic as the industry adjusted to the challenges of remote working. Overall, regulators have been extremely pragmatic during the pandemic, highlighted by their flexibility in changing or, in the case of MDR, delaying regulation implementation to give companies more time and ability to focus on the pandemic.
New ways of working developed during the pandemic, which fostered greater collaboration and empowered companies to use technology to their advantage, must continue in the future. The pandemic has proved that technology will play a key role in driving the industry forward, enabling us to move faster than ever before.
Challenges are temporary: the industry remains strong in adversity
It has been, and continues to be, a difficult period for the industry, but these challenges are only temporary. It is crucial that we learn from the past year and continue to move forwards, taking the necessary steps to modernise and future-proof the industry. There are many positive changes and lessons that we can take from the past year, and the challenges faced will only serve to make the industry stronger.
