Time is of the essence to prepare for the major regulatory changes that will come with the new European regulations on medical devices and in vitro diagnostics (IVDs), industry experts said at the Association for Advancement of Medical Instrumentation (AAMI) conference on Friday.
Sessions focused on MDR/IVDR underscored a harsh reality for many in the medical device industry: The need to invest the time and resources to prepare and comply.
Some of the significant changes to the regulatory landscape include a greater role of notified bodies (NBs), a tightened clinical evidence definition, risk-based classifications, and the no “grandfathering” rule, which directs all existing devices to comply with the new regulations by the end of the transition periods for MDR and IVDR — three and five years, respectively.
The concerns with the new regulations slightly differ between among manufacturers of medical devices and IVDs with a presence in the European market.
For example, there is a lack of historical data on IVDs because such data are not being collected in the same way as for medical devices, said Ian Purdy, senior vice president of quality and regulatory affairs at Haemonetics, a provider of blood and plasma supplies and services.
MDR being “essentially silent on what are the triggers for conducting a new clinical investigation when a device is changed or modified,” makes this determination even more difficult for device manufacturers than it already was due to the associated costs and time, Ibim Tariah, technical director at BSI, noted.
A shared concern relates to the expected lack of NBs to meet demand as the increased requirements and expectations could cause some to lose interest in obtaining designations.
“No matter what numbers you look at, there’s going to be a lot less NBs,” Purdy said.
Some key steps that can help along the way with preparing for IVDR, according to Purdy, include selecting the right NB by ensuring their continued availability, communicating clearly to senior management that the time is now to invest in the right resources, such as training for personnel responsible for regulatory compliance.
He also urged industry to invest in product management systems to drive data gathering.
“Fix this now because every bit of data that comes in is going to help you over time,” he said.
On MDR, some of the areas that manufacturers should pay “special attention” to when it comes to deciding when to conduct clinical investigations to ensure safety and effectiveness, according to Tariah, include new design features, materials, intended purposes, medical indications, target use populations, and claims, among others.