- Notified body BSI has issued a conformity certificate to a Novartis inhaler under the incoming EU Medical Device Regulation, the first of its kind under the new regs set to take effect next year.
- Under the older EU Medical Device Directive, the product was regulated as a Class I device and didn't require notified body review.
- Under the incoming regulations with more stringent rules, the product is classified as a Class IIa device and necessitates review.
The MDR, which takes effect May 26, 2020, will require a plethora of devices that formerly didn't need review by a notified body to undergo review. But with only four NBs certified so far to review under the new regulation, there's a great deal of uncertainty about whether companies will be able to find a NB to certify their devices in time.
The new regulations, passed in May 2017, are intended to boost the intensity of pre- and postmarket review for medical devices "in order to meet common safety concerns." But designation of NBs has lagged and several have exited the sector, stoking fears there will not be adequate capacity to deal with the new regulation's requirements.
"The increased requirements on manufacturers and notified bodies means the BSI team is experiencing increased pressure to meet the new regulatory assessments ... We continue to work towards certifying more devices under the MDR to the tight timelines outlined in the Regulation," Gary Slack, senior vice president of the notified body at BSI, said in a release.
Device industry groups in the United States and Europe have expressed concern the regulatory system will not be ready in time, leaving member companies in limbo.
"The change in regulation is very substantial," Alison Dennis, a partner at the Fieldfisher law firm, based in London, told MedTech Dive. "Everyone has to completely recertify all of their devices under the MDR."
And the NBs cannot start work on those reviews until they themselves are fully certified, she said.
"The practical problems are as follows: you've still got to get a notified body to reissue your certificate," said Oliver Bisazza, director for regulations and industrial policy at industry group MedTech Europe. "Notified bodies are struggling to do that because there's an enormous workload."
But so far the EU has not indicated it will delay the implementation of the new regulations despite the capacity issues.
If the moving parts don't all come together before the deadline, "there could be a temporary disruption to keeping CE-marked products on the market," Bisazza said. "Manufacturers are expected to do their best, update files and processes and hope everything works out in the end," he said.