The EU Medical Device Regulation (MDR) has been a source of stress for medical device companies around the world. Before COVID-19 transformed the industry, there were still many companies that weren’t on track to meet the original deadline for application.
Then, in early April, the European Commission—the organization that makes and implements regulatory decisions in the EU—proposed a delay. The extra year will give medical device companies more time to become compliant with the new regulation and more space to prioritize efforts addressing COVID-19.
On April 17, the European Parliament voted to officially adopt the proposal, and on April 24, the member states accepted the delay, and it was officially published in the Official Journal of the European Union. The original date of application was May 26, 2020, but the proposal moves that date to May 26, 2021.
This delay isn’t a panacea, however. The pandemic will continue to stretch already-strained budgets and plans, meaning that the resources freed from an extension might be consumed by the renewed need for medical supplies and personnel.
During this extended period, medical device companies should take a careful look at the widespread effects of this pandemic and learn how they can design internal infrastructures that will keep them adaptable to this change and others down the road.
What changes will come from the EU MDR delay?
The primary change is the one-year postponement of the date of application for the EU MDR. If you got an MDR or MDD certificate prior to May 2020, it will also be valid for longer, as you can see below.
The new date of application creates more flexibility for starting clinical investigations and adopting common specifications. That said, this delay doesn’t mean all timelines will shift. Some timelines will remain the same, meaning medical device companies will have to keep a close eye on which dates are relevant to their plans, which will shift, and which won’t.
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The delay enables medical device companies to start clinical studies before the new enforcement date and to continue them after. Common specifications, the technical and clinical requirements that give companies a way to comply if there aren’t harmonized standards, won’t be adopted until the new date of application.
As a result of this delay, the European Commission will also have another year to verify the functionality of European Databank on Medical Devices (EUDAMED).
Not everything will change as a result of the postponement of the regulation’s date of application.
The “grace period” for devices with existing MDD certificates that were issued prior to May 2020 will still end on May 26, 2024. Additionally, the enforcement date for the In Vitro Diagnostic Regulation (IVDR) remains unchanged. The dates of application for the MDR and the IVDR will now fall closer together––only a year in between––so that might create more strain for already-overworked Notified Bodies.
As timelines shift or stay the same, medical device companies will likely uncover some remaining ambiguities in between.
The extension, as is, doesn't offer amendments to Article 120 section 3, for instance, which means manufacturers may still need to meet some MDR requirements by the original date of application. It might also mean companies will still need to meet the MDR requirements for post-market surveillance by the original May 26, 2020 deadline.
Why is the European Union delaying MDR enforcement?
The reason for this delay is COVID-19. The coronavirus pandemic has introduced unprecedented changes that the European Commission admits it couldn’t have predicted when setting the initial MDR date of application.
The goal of the EU MDR is to better serve public health, and the decision to delay its enforcement is intended to do just that. Though some medical device companies will relish the extension this gives them to become compliant, this is only a secondary benefit to the delay that serves that larger mission for the medical industry and the patients.
MDR threatens medical device Supply at a vulnerable time
The European Commission produced a document explaining the proposed delay. The contributing authors focused on the exceptional circumstances of the pandemic and the potential for the MDR’s original date of application to stress an already strained health care system.
The EU MDR and its original date of application already threatened to take some products off the European market, at least for a time. Stricter and more numerous standards would have forced many companies to remove products from the market if they weren’t able to make them comply.
Initially speaking, there would have been negative side effects to this regulatory change, but, at least according to the European Commission, the transition cost would have been worthwhile. That cost calculation has changed with the emergence of COVID-19.
Now, taking medical devices off the market when the market may need them the most is untenable.
Margaritis Schinas, vice president of Promoting Our European Way of Life, said in a press release, “Shortages or delays in getting key medical devices certified and on the market are not an option right now.”
In a time of shortages, a period when public health is suffering in a way that hasn’t been experienced in a century, the medical device industry and the European member states can’t allow medical device availability to go down.
Economic health is as important as public health
Medical devices that might have faced retraction or removal due to the original MDR enforcement date could help during the pandemic.
Capital Economics, a research firm in London, predicts that the pandemic could cause a 15% drop in GDP in the EU. German Chancellor Angela Merkel said that the EU is “facing the biggest test since its foundation.”
In this context, a regulation that makes devices noncompliant and forces companies to retract or modify them is too big a risk. Companies that have to pull devices or spend precious resources modifying them could experience lower revenue and, in this environment, layoffs or closures.
The European Commission wants medical device companies to focus on filling device shortages—both to serve public health and to maintain as much economic stability as possible.
Compliance challenges will only get harder
If the delay hadn’t passed, many companies would have had to spend resources seeking compliance when those resources could have been fulfilling pandemic-related demand.
As the pandemic continues, or if it resurfaces later this year, the requirements companies would be trying to fill would get increasingly impractical.
Medical device companies, Notified Bodies, and EU Authorized Representatives are all responding to the new requirements of social distancing. New work-from-home environments will likely create some inefficiencies as these organizations adjust, but they also make it difficult to complete any in-person work, such as audits.
The Medical Device Coordination Group released guidance documents meant to help Notified Bodies do in-person and remote audits safely. These documents note that Notified Bodies can use remote technologies, such as video conferencing tools, to complete surveillance and recertification audits.
The Medical Device Coordination Group also advises Notified Bodies to clearly mark that an audit was done remotely and, if necessary, to mark that they’ll follow up with an in-person audit as soon as it’s possible to do one.
Some work, however, is hard, if not impossible, to do from home. Travel restrictions mean that clinical trials, for instance, will be harder to conduct and complete. The impracticality of seeking compliance further incentivized delaying the enforcement of EU MDR.
How should you react to this delay and plan for future EU MDR changes?
The EU MDR delay is likely not the last major change the medical device industry will see as a reaction to COVID-19.
The European Commission is creating slack where it can in an already-strained system, but that slack is likely to tighten.
As such, it’s better to plan for what might happen rather than react to what appears to be happening. Do the former and you stand a chance of staying ahead of the effects of this pandemic. Do the latter and you’re bound to remain behind.
Plan proactively, not reactively
Josh Kopelman, partner at First Round Capital, warns, “The risk of ruin increases with time.”
Companies that do nothing are committing, according to Kopelman, an “omission bias.” Reacting to changes only as they come might feel neutral, but it’s a surrender to circumstances evolving around you without your input. For medical device companies, that means assuming the world will return to normal in a year, and that all you need to do is wait out the pandemic and the delay.
Ultimately, the EU MDR delay isn’t one delay. It’s going to cause a cascade of other delays—only some of which can be foreseen. It’s also likely a leading indicator of other incoming changes to come.
Medical device companies must take a clear-eyed view of what advantages they currently have and then leverage them however possible.
This delay isn’t just a lucky break––it’s a chance to design plans and processes that focus on quality. An investment in quality pays dividends: a reduced regulatory burden, higher production yields, reduced overhead, increased patient trust, and more.
Companies that weren’t going to be ready for the original date of application will now have more time to complete the transition. It’s best not to waste it.
Adopt Best-in-Class tools that keep you nimble
Medical device companies were already struggling to move fast enough to meet the MDR transition deadline—far before COVID-19 started spreading.
According to our 2020 State of Medical Device Product Development and Quality Management Report, as of the end of last year, 9 out of 10 companies believed they would not be ready for the MDR’s original date of application.
Clinical evidence and availability of Notified Bodies were among the areas of compliance medical device professionals were most concerned with (42% and 41%, respectively). These areas will only get more difficult with the pandemic.
Our research also revealed an effective solution for staying ahead of the curve: best-in-class tools to manage quality and regulatory. About half of companies using best-in-class tools were either fully transitioned to EU MDR or were confident they would be compliant by the original 2020 enforcement date. Fewer than one in three organizations utilizing legacy QMS solutions said they’d be ready.
An investment in best-in-class tools was one of the best predictors for whether a company was prepared for the original EU MDR date of application. For forward-thinking companies, the one-year delay is a chance to adopt these tools and leverage them to prepare for the new date of application.
Greenlight Guru is made by medical device professionals, for medical device professionals. This means it’s purpose-built, both for the everyday purpose of managing quality and risk and for the rare events like these, when everything shifts and you need to keep track of it all.
From crisis to paradigm shift
There’s a question hiding behind every change as a result of the pandemic, from changes in our everyday lives to changes in regulatory regimens: Is this temporary, or is this permanent?
McKinsey & Company is blunt about what we should expect. The pandemic won’t be a single, dramatic event, McKinsey says, but will instead introduce “the next normal.” For medical device companies, perhaps more than any other industry, this time will be defined by the pre-COVID-19 era and the post-COVID-19 era.
In moments of crisis, illusions and assumptions tend to fall away. Solutions and processes that once seemed good enough will be exposed as inefficient, wasteful, and ineffective. As companies shift to meet the demands of this next normal, they won’t be able to depend on the return of the old normal.
This is the time to create new processes, adopt new tools, and design new ways to foster collaboration and promote innovation. The new normal will demand a proactive stance. With a purpose-built system, you can streamline your planning and operations, all while maintaining enough flexibility to adapt to new changes. When the EU MDR finally becomes a reality and its downstream changes go into effect, you’ll want to be able to be flexible.
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