Europe has overhauled its regulations on medical devices, imposing far more stringent requirements that will phase in over the next three to five years.
Device regulations dating to the mid-90s have not kept pace with the fast-changing industry. Current directives, for example, require only a critical evaluation of published literature for approval of new products functionally similar to existing ones. New directives that took effect in May require Class III and implantable devices to undergo a clinical investigation to show that the new device is equal or superior to other products on the market.
They also expand the list of devices that fall under the Class III designation to include spinal implants, devices that monitor and control active implants, nanomaterials, apheresis machines and combination products.
Because their implications are complex and far-reaching, the new rules have extended phase-in periods—three years for those governing medical devices and five years for those concerning in vitro diagnostics. These lengthy transitions are intended to give the industry ample time to prepare for these and other changes:
Notified Bodies that assess products must be recertified and redesignated and will be required to conduct unannounced manufacturer and supplier audits.
Widespread product classification changes will have pronounced impact on in vitro diagnostic devices, redesignated from Class A (lowest risk) to Class D (highest).
Make full use of the three- and five-year transitions, avoiding the temptation to do business as usual and play catch-up as the final implementation dates draw closer. In particular, companies that are improving existing devices must perform gap analyses to determine if literature-based clinical evaluation will suffice, or if the revised products will require evidence from clinical investigations.
Guest Contributor Joanne Emmett is VP, medical devices, at Premier Research. Jo oversees teams around the world, ensuring that each of the company’s teams is made up of the right people at the right time with the right skills to advance new and creative drug and device development practices. Working with Premier Research resources and customers, she makes certain that their personalities and work styles are thoroughly compatible with those of the client. Jo’s past operational experience within large and small CROs brings to Premier Research a strong and diverse skill set focused on customer service.
This article was reprinted from Volume 24, Issue 07, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>
