EU regulation of medical devices is hindering access to new innovation by patients in Ireland and across Europe, according to the head of one of the biggest companies in the sector.
Stryker chief executive Kevin Lobo said the European Medical Devices Regulation (MDR) was very onerous and had slowed down the approval process for new treatments.
The regulation has been phased in over recent years but all medical devices on the market are required to be compliant with the new regime since May.
“Traditionally, we used to launch products in Europe faster. The CE [Conformité Européene] mark was faster to obtain than the [equivalent] 510K in the United States. Now, it’s much slower,” Mr Lobo said.
“It was well-intentioned, the EU MDR, but it became extremely onerous,” he said. “There are [now] many products that are low volume that we’re just not going to bring here”.
Stryker is one of the top three medical device companies worldwide by market capitalisation and top six in terms of sales. The group employs more than 5,500 people at nine sites in Ireland, including several at the cutting edge of medical technology.
Mr Lobo accepted that the regulatory reform had been triggered by a couple of “bad outcomes”. That includes a scandal involving substandard breast implants that leaked, made by a French company. Tens of thousands of women had used the affected products. The concept of software as a medical device was another factor driving the need for the updated EU regulation.
“That caused what I think is an overreaction on the regulatory front. It’s a new change and I hope the politicians realise that it was an overcorrection,” Mr Lobo said, acknowledging there was intense lobbying effort from the industry to roll things back.
“Unfortunately, European consumers are going to have to wait for some of these great technologies. They’re going to take longer to arrive in Europe.”
Previously, smaller innovative start-ups would first seek approval in Europe, where the process was seen as cheaper, faster and with more predictable outcomes. Mr Lobo said that process had been disrupted by the legislation. “That’s really a problem right now. The European start-ups are having to go to the United States.”
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