Maggie Fick, a reporter with Reuters.com, published an article titled ‘Medical device makers drop products as EU law sows chaos’ on 19 December 2022, commenting, quite accurately “A law created to stop one criminal company’s actions 10 years ago now endangers patients’ lives, including children, and European manufacturing sites. Is that what the EU wants for its citizens?”
Fick spoke with eight companies from various EU countries plus medical associations and individual doctors, and all expressed significant concern that the requirements were stretching the time it takes to get a certificate for a product line to as much as two-and-a-half years, compared with a few months under the old system. In addition, the companies report that costs have surged, by between three to ten times. As a result, some companies are simply allowing their device certifications to lapse, meaning that hospitals in the EU can no longer use their devices.
Doctors, in Austria, Belgium and Germany said in some cases they were unable to provide their standard quality of care because devices for routine procedures were no longer available. Hospitals in Austria and Denmark have reported shortages of critical devices and the French regulator reports that the country’s health system was being affected by shortages of various types of device.
An Irish device manufacturer advised that to get a new laparoscopic device, cleared for marketing in the US two years ago, on the EU market has taken 18 months with a total cost of €100,000, while under the previous EU system, it took about €15,000 and a few months to get a similar device approved.
Doctors say the starkest example of the impact of company decisions to drop products has been on devices for rare conditions, such as catheters used on newborns with heart problems. “We’re going back in medicine by 20 to 30 years”, commented a Belgian director of pediatric cardiology, because he had lost access to a special catheter used to enter the atrial septum of a newborn’s heart via the groin, which needs to be done within five minutes of birth.
Although the Commission has now promised to delay the deadline for compliance with the new regulation, exactly how this will be introduced and under what conditions, will not be known until mid-January at the earliest. It may be already too late to save the EU availability of some devices, however. This is not the result that the Commission was expecting when they touted improved safety of medical devices for EU citizens back in 2017, but to many, this was inevitable, given the complexity of the regulation and the disappearance of two-thirds of the notified bodies. Are any of the MDR authors still claiming that patient lives will be saved by the new rules?