Medtech sector faces regulatory quagmire

Medical devices save lives. By definition, therefore, anything that impinges on their use costs lives.

Right now the European medtech sector is facing a raft of regulatory challenges. At heart is the European Union’s Medical Devices Regulation (MDR), which came into effect in May last year.

Some of the changes it wrought are welcome.

“Under the Medical Devices Regulation, software and digital technologies may be classified as medical devices,” explains Bridget Clinton, an associate at law firm Arthur Cox.

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“The Medical Devices Regulation provides a robust regulatory framework at EU level which ensures a level of harmonisation in terms of clinical safety, certification, regulatory oversight and market access. The Health Products Regulatory Authority [HPRA], industry groups and stakeholders have collaborated in relation to the Irish regulatory position and the HPRA has delivered training on the updated regime.”

The MDR is also intended to protect patients from dodgy goods, such as leaky breast implants.

However, because the new rules require medical devices to undertake re-certification by May 2024, a massive undertaking, fears are growing that it may in cause harm by putting patient access to medtech at risk.

“Medtech, in-vitro diagnostics and digital solutions are used for the prevention, diagnosis, monitoring and treatment of diseases and other conditions. There are more than 500,000 different types of medical technologies on the market, ranging from glasses and wheelchairs to pacemakers and MRI scanners,” explains Sinead Keogh, Ibec’s medtech and engineering sectors director

“To get into the health system, manufacturers must demonstrate that medical technologies meet EU-wide safety and performance requirements. These are assessed by notified bodies which grant approval for products which conform with the regulation and award CE marks.”

The MDR represents the greatest change for the regulatory system in more than 20 years.

“While the medtech industry is a proven supporter of the EU MDR’s goals, and has invested significantly into the transition process, major unintended bottlenecks still need to be addressed by policymakers, as highlighted by data revealed in a survey conducted by MedTech Europe, which was supported by the Irish Medtech Association nationally,” says Keogh.

Access to medtech is now a concern.

“Certification bottlenecks due to insufficient notified capacity are predicted to contribute to a 27 per cent discontinuation of medtech due to a shortage of notified bodies with less predictability. Some one in four products will come off the market,” she warns.

Preventing critical shortages of medical devices is paramount. “As much as 85 per cent of the 500,000 devices covered by the medical device directive are yet to be certified under the MDR,” she points out.

There is also a need to address unmet clinical needs and innovation. Says Keogh: “Not only are 43 per cent of companies no longer making any changes to improve devices that are in the health system, but nearly half (46 per cent) of medtech companies across the EU are putting innovation projects on hold here.”

At the time the survey was issued between 15-30 per cent of start-ups said they had no access to a notified body. “Many start-ups have now sought regulatory approval through the more predictable US FDA process, pushing some of the most innovation solutions stateside, for the benefit of US patients,” she adds.

“We’re calling for the extension of the medical device directive and active implantable medical device directive certificates to enable product stay on the market until such time as capacity is built into the system, amongst other solutions,” says Keogh.