GAMETIME FOR NOTIFIED BODIES: This Sunday, the starting gun fires for the Continent’s notified bodies. (We never tire of using the relay race metaphor to describe implementing the EU’s new complex, multi-stage medical device regulations.)
It’s the first day bodies can apply with national authorities to keep doing their job of assessing the quality and safety of medtech. After scandals involving silicon breast implants and metal-on-metal hips, notified bodies will be held to a higher standard. A new range of products must now pass muster as well, so a big question in the industry is which notified bodies will claim competence to evaluate the new sub-categories, particularly in vitro diagnostics.
Capacity concerns: We can’t understate the anxiety in the industry around this process. There are hundreds of thousands of types of devices on the market and they’ll all have to cycle through notified bodies under more exacting standards if they’re going to be on European shelves during the next decade. There’s deep fear there won’t be enough evaluators to go around and that manufacturers will be left out in the cold — that some notified bodies will decide it’s not worth the trouble, or that many will hang back, waiting to see how things go for the first tranche of applicants before starting the process.
Cause for optimism (maybe): Most members of the Brussels trade group for notified bodies Team-NB plan to enter “the pipe as soon as possible,” Director Françoise Schlemmer told Morning Health Care. According to a September survey, 86 percent of Team-NB’s members said they plan to apply in November. Another 8 percent will try next month, with only 8 percent saying they’ll wait until next year. There are currently 56 notified bodies in the EU, mostly private companies. A bit under half of them are in Team-NB, responsible for more than 80 percent of the certificates issued, Schlemmer estimated.
During an October meeting of notified bodies in Brussels, the more than 40 in attendance all said they planned to re-apply, Schlemmer said. However, only “10 to 12 of them” said they’d try to get designated for IVDs. That could be a concern: About 85 percent of the 40,000 types of IVDs will have to go through the approval process for the first time.
Marathon, not a sprint: Beyond Sunday’s deadline, the wait for the next stage won’t be a short one — few expect the first notified bodies to be approved before 2019, which leaves less than a year-and-a-half for medical devices to be evaluated. Team-NB said it’s trying to speed up the process by figuring out what types of changes established notified bodies need to make to satisfy national regulators. “That will diminish the work of designating authorities, hopefully, and will allow them to go quickly,” Schlemmer said.
Not everyone is poised to begin: My colleague Rosemary Belson checked in with 3EC in Slovakia, which isn’t a member of Team-NB. It’s not planning to apply until the beginning of next year, said Deputy Director Ľubor Lysák. Though there’ve been some complaints that the European Commission and national authorities were slow to provide information on the assessment process, Lysák said that’s not a concern. We “just want to take time and prepare well,” he said.