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Device Makers Could Face Approval Lags Under New EU Rule

Dec. 11, 2018, 11:36 AM

The European Union compliance clock is ticking for the medical device industry, including giants like Medtronic Inc., Fresenius Medical Care, and Stryker Inc.

They’re facing a deadline of May 26, 2020, to get their products recertified as compliant with the EU’s new Medical Device Regulation (MDR). It replaces a decades-old regulatory framework in the EU. There could be a logjam of applicants and delayed approvals and supply disruptions if device companies don’t start preparing now to meet the new requirements, three device industry specialists told Bloomberg Law.

And there’s an even earlier deadline—just one month away, in January 2019—for devices considered higher risk that requires companies to consult with their respective Notified Body—regulatory review panels in EU countries—to evaluate potential compliance issues that could hinder recertification.

It is unclear how many devices will be affected by the deadline for higher-risk devices, but they include the most sophisticated and life-saving health-care products, including some that have been on the market for decades, Jaap Laufer, medical director for Emergo by UL, told Bloomberg Law. Emergo is a global health-care consulting firm.

“So, regardless of the number, the disruption of vital product supply may be much larger than expected,” he said.

But there’s a chance this deadline could get pushed back because processes necessary for these high-risk device consultations are not in place, Ronald Boumans, senior global regulatory consultant at Emergo UL, told Bloomberg Law Dec. 7.

As the new regulatory regime shakes out, there’s a lot of money at stake. The global device industry is currently valued at $389 billion and could reach $438.8 billion in 2022, according to research firm Kalorama Information.

The EU MDR replaces Directive 93/42/EEC for medical devices (MDD) and Directive 90/385/EEC for active implantable medical devices (AIMDD).

The new regulation aims to minimize country-by-country differences in device regulations and product quality and to improve control of medical device reporting. The older framework lacked uniform requirements for Notified Bodies in different countries and had no centralized database for tracking devices as they moved through the health-care system.

The new MDR is more encompassing than its predecessor rule.

The older framework didn’t cover distributors and importers, and high-risk devices weren’t subject to pre-market review.The MDR ramps up requirements for scrutiny of new and innovative products, post-market surveillance, and clinical data and evidence for most products, Laufer said. The requirements for Notified Bodies have also been strengthened and made more uniform.

Rush to Deadline

There likely will be a rush to get devices recertified by Notified Bodies in 2019 and 2020. But not meeting the deadline will have potentially significant financial consequences.

For example, if a company fails to have a device recertified, the company will be barred from selling the product in the EU. And the company could be exposed to potential liability for defective device components provided by their suppliers.

“Right now, there are 500,000 different types of medical devices and supporting technologies that are supplied to the EU, and each one will need to be reviewed for compliance with the new regulation,” Mike Edwards told Bloomberg Law in a telephone interview. Edwards is the director of product management at the quality and regulatory management software company Sparta Systems in Hamilton, N.J.

Companies with lots of devices shouldn’t wait until the last minute to certify. With more devices subject to the certification process than before and fewer Notified Bodies certifying, the process may take longer, Edwards said.

And there is uncertainty whether Notified Bodies will have the capacity to certify all devices, particularly niche devices that require highly specialized expertise or devices that are classified higher than they had been under the MDD, Nicole Denjoy, secretary general of COCIR, told Bloomberg Law. Brussels-based COCIR is the European trade association representing the medical imaging, health information communication technology, and electromedical industries.

What was once a two-month device certification process could now take much longer, Edwards said. And even then, the devices could get rejected if the new regulation is misinterpreted by the manufacturer.

Elements Still Developing

Meanwhile, several core elements of the new regulation are still under development.

One of those is the European Databank on Medical Devices (Eudamed Database), aimed at strengthening market surveillance and transparency for medical devices by providing national authorities with quick access to information. The Eudamed Database won’t go live until March 2020, Denjoy said, which leaves only two months to register manufacturers and devices in this database before the May 2020 compliance deadline.

Also, several guidance documents, including in the areas of clinical evaluation and post-market surveillance, need to be published, she said.

Hurdles in Race to Recertification

The hurdles facing companies as they race to get their devices recertified include providing enough clinical data to show their devices comply with the new regulation. More devices fall under the new regulation, and they are subject to stricter review standards.

For example, accessories, sterilization products, and device software weren’t captured under the predecessor regulation. Equally significant is that all older devices need to meet the new regulation requirements too.

The hardest and most expensive compliance issues for companies will be recertifying existing devices and the higher classification of some devices, Edwards said.

For example, the new regulation requires most software devices to undergo Notified Body review where before some low-risk devices were exempt.

The requirements for more extensive clinical data on devices are likely to be expensive, Laufer said.

“In cases where companies have to generate much more clinical data or go back and gather such data retrospectively, that is probably the most expensive,” he said.

To contact the reporter on this story: Dana A. Elfin in Washington at

To contact the editors responsible for this story: Fawn Johnson at; Randy Kubetin at