Devicemakers face steep challenges due to a decline in the numbers of notified bodies, and industry is already seeing a culling of the weakest bodies.
Manufacturers already are feeling the squeeze, and some remaining notified bodies are deciding to not issue quotes for new clients, expert said.
In fact, 25 percent of notified bodies have stopped operations ahead of the upcoming regulations, and that number should only increase, Gert Bos, executive director and partner at Qserve Group told attendees of the recent Regulatory Affairs Professional Society Convergence Conference in Baltimore, Md., last year ().
A big change will be the requirement for a certificate of all class 2b implants. That will “force us to be much busier than we currently are,” said Suzanne Halliday, head of medical devices notified body, BSI.
Halliday presented BSI’s approach to the looming changes when it comes to conformity assessments during her organization’s joint meeting with the Association for the Advancement of Medical Instrumentation March 9 to 10. The group has taken a divide and conquer approach, bringing in people with different expertise to cover areas such as quality systems, microbiology, technical documentation and unannounced audits.
Bos and Erik Vollebregt, partner at Axon Lawyers, noted in an October 2015 BSI white paper that “manufacturers are facing problems due to decline in numbers of notified bodies as well as decisions from many remaining notified bodies to not, or only selectively, issue quotes for new clients, or even for new work under existing contracts.”
EU and UDI
Another challenge facing device manufacturers supplying products in the EU is UDI. Lena Cordie, owner and consultant with Qualitas Professional Services, gave an overview of what industry might expect in this area in coming years. She cautioned that while device manufacturers with products on the U.S. market have had some guidance from the FDA, things will look different in the EU, and manufacturers should expect to do a lot of work.
“Don’t look at this as just a project” that companies can wrap up — it’s an ongoing process, she said.
Cordie highlighted some of the differences between the EU and U.S. For example, in the U.S., the labeler is responsible for establishing the UDI for devices, while in the EU, it’s the manufacturer. Further, while the U.S. has established the Global Unique Device Identification Database, the EU has the nascent EUDAMED database.
Still, she said, those companies doing unique device identification in the U.S. should be able to comply with the EU regulations, with a few modifications. That is because the U.S. will require 62 data elements, whereas the EU will only want 33. For example, the FDA will want information on the sterilization method and packaging type and status, while EU officials will not.