There comes a time in every relationship where you have to pause and ask: Do we really have a future together? That time for reflection is now for medtech companies serving the European market as regulatory reform and increased oversight threaten to put a slew of Notified Bodies out of business.
Standardization of practices and a commitment to quality are the objectives of this increased oversight—not the reduction of Notified Bodies. But it’s a logical consequence.
“Already in the past 15 months, Europe has seen a restriction on its Notified Bodies both in the voluntary and the mandatory phase of the joint audit program. An increasing number of Notified Bodies is closing down, is restricted in scope or is under (partial) suspension,” says Gert Bos, head of regulatory and clinical affairs at BSI and president of the Notified Body association TEAM-NB. “Part of this is forced on them; but, in a number of cases, Notified Bodies ask for restrictions before the joint audit, or they close down altogether.”
At the time of publication, there were 75 Notified Bodies listed in the European Commission’s Nando database; predictions for how many Notified Bodies will remain after the dust settles seem to range from 50 to as low as 20.
Mergers, acquisitions, and the formation of cooperative groups will further chip away at the number of Notified Bodies, according to Bos. “It seems [inevitable] that the number of Notified Bodies will continue to drop, and it might go down further when the new regulations require Notified Bodies to apply for designation from scratch without grandfathering,” he adds.
So, what does the diminishing pool of Notified Bodies mean for medical device manufacturers?
Well, it means that device makers better take a long, hard look at their Notified Body and assess whether or not it is more likely to emerge from the scrutiny unscathed or to become a casualty of the quest for quality.
“There will be manufacturers within the next two years that will have an existing certificate but no Notified Body for that certificate,” says Peter Havel, senior vice president of medical & health services, TÃV SÃD. “So, if they can't keep up surveillance, they won't be able to keep up their certificate.” That’s a pretty serious consequence, and a situation no manufacturer wants to deal with.
Some manufacturers don’t just stand to lose their certificate, however. Those device companies that intentionally selected a particular Notified Body based on a reputation for being easy may find themselves both without a certificate and lacking the necessary requirements to pass muster with another Notified Body.
That's not all manufacturers should be thinking about, though. The narrowing field of Notified Bodies may also be a good motivator for major medical device manufacturers to harmonize their quality management systems, according to Havel.
“10 years ago, a company would integrate the quality management system (QMS) of the merger or acquisition into the corporate QMS,” Havel says. “Now, where the big manufacturers do less of their own development but compete with each other in acquiring companies, the acquisition speed got so big that the decision was not to integrate the acquired QMS into a corporate one in many cases. That might really be the biggest challenge for the larger manufacturers.” Havel adds that some manufacturers may currently have anywhere from 10 to 20 Notified Bodies, some of which may not have a promising outlook.
As the new regulatory reality in Europe begins to set in, medtech companies need to reevaluate their Notified Bodies with the future in mind. Is it time to fully commit or to end the relationship and move on?
Shana Leonard is group editorial director, medical content, at UBM Canon.