A recently passed law by the European Commission (EC), meant to improve safety standards for medical devices in Europe, has led manufacturers to pull life-saving products from the shelves for failing to meet the new criteria.
This has led to a massive bottleneck, as thousands of medical devices seek re-approval before the 2024 deadline, according to latest data.
The European Union’s Medical Devices Regulation (MDR) act, which came into effect on May 2021, required that all medical devices ranging from implants and prosthetics, to blood glucose meters and catheters, to meet the stricter safety standards.
Manufacturers To Submit Almost 25,000 Devices For Re-approval
Devices covered under the older inspection certificates need to be recertified under the new MDR regulations by May 2024 and in certain cases, even earlier, to stay on the market.There were almost 23,000 valid certificates under the old system that have yet to be reapproved as of October.
At least 25,000 medical device certificates were affected by the act, but manufacturers have only submitted applications for 8,000 of them to comply with the new system.
The remaining backlog of medical devices that still need certifying only fell by 5 percent from April to October 2022, according to an EC survey.
The number of applications under review by regulators grew by 20 percent during that same period.
Some certificates cover multiple devices, while others cover entire product lines, which complicates the process.
Device Makers Struggling to Comply
Eight European medical equipment manufacturers told Reuters that although most of the withdrawn products would have little impact on the health sector, many other devices were still medically vital.Since the passage of the MDR act last year, medical equipment costs have risen by about three to ten times, as companies were forced to let many of their product certifications lapse in the rush to make the 2024 EC deadline.
Hospitals in the EU will no longer be able use many important medical devices due to these new inspection rules.
The eight manufacturers said that the new EU rules extend the time it will take to get a product line certified from only a few months under the old system to almost two-and-a-half years.
The EU Commission told Reuters that they were “concerned about the pace of the implementation of the new regulations” and would do all they could to “ensure patients have access to the medical devices they need.”
John O'Dea, the CEO of Palliare, an Irish medical equipment manufacturer, told Reuters that he was willing to pay extra to get his company’s new laparoscopic device onto the market, despite the financial pain.
Under the old system, it cost him about 15,000 euros and a few months to get a similar device approved, but it has taken over a year so far under the new system, costing his company about 100,000 euros.
Meanwhile, his device was already approved two years ago by the U.S. Food and Drug Administration.
Even some of the largest medical product companies are having problems preparing for the new system’s complexity and costs.
Getinge—one of Europe’s biggest manufacturer of surgery, intensive care, and sterilization equipment—has been struggling with a bureaucratic headache in order to make the EU regulatory deadline on time.
The firm said it had removed a third of its products with little effect on profit, but the recertification of the remaining two-thirds was strenuous and took far longer than expected, Mikael Johansson, a Gitinge executive, told Reuters.
The new and more costly approval process has been a major blow for Europe’s $150 billion medical device market, which is the second-biggest in the world.
Basic Equipment Shortages Becoming Problem, Pulling Medical Tech Back A Generation
Two medical associations, three doctors, and two regulatory experts interviewed by Reuters agreed with the companies that the MDR was causing widespread disruption and shortages of vital equipment.The Standing Committee of European Doctors (CPME), a group of national medical associations, and France’s national medical regulator (ANSM), told Reuters that the health systems Austria, Denmark, and France respectively reported shortages of various devices since the passage of the act.
Austrian, Belgian, and German doctors complained that they were unable to provide their standard quality of care in certain cases because the devices for routine procedures were no longer available on the market.
Doctors have been complaining that the equipment withdrawals have had the biggest impact on devices used to treat rare conditions.
“Those are minutes in a child with little oxygen going to its brain,” Marc Gewillig, director of paediatric cardiology at the University Hospital Leuven in Belgium, told Reuters.
“We’re going back in medicine by 20 to 30 years,” he said, referring to the loss of a particular catheter used on newborns with born with a heart condition.
Gewillig claimed that he lost access to nearly a dozen devices needed for the special procedure, along with the catheters, forcing him to improvise on three infants and delaying each operation by 30 minutes.
Eurocrat-Led Gridlock and a Potential Fix
An EU Commission spokesperson told Reuters that a single cause would not be enough for regulatory agencies to recertify products and blamed device makers for not preparing enough for the changes to the regulations.Brussels has ordered 36 agencies to handle the logjams and is considering 20 more to process applications, according to the spokesperson.
However, Kyriakides announced at the Dec. 9 meeting that a delay would be considered to improve the implementation of the new MDR regulations.
“We all knew the transition to the new rules would be challenging, both for Member States and for industry,” Kyriakides said.
“Patient safety is always paramount.”
“The transition to the new rules has been slower than we anticipated. The pandemic, shortages of raw materials caused by Russian war against Ukraine and low notified body capacity has put a strain on market readiness, she continued.”
The May 2024 deadline may be extended to 2028 to give companies more time to comply to prevent medical equipment shortages, but this will require the European Council and Parliament to pass an amendment to the law, which will not take place until next year.
“We are facing a risk of shortages of life-saving medical devices for patients. This this is a risk we cannot take,” said Kyriakides, who proposed that the EC extend the transition period of the MRC to “mitigate any short-term risk.”
The amendment would include staggered deadlines, depending on the risk of each device.
High risk devices would get a new deadline of 2027, while medium and low risk devices would be valid until 2028.
She also suggested that the extensions would be subject to certain conditions and that only devices which are considered safe would benefit.
The EU Health Commissioner also recommended the removal of the May 2025 sell-off date to prevent safe medical devices already on the market from being discarded.
