January 04, 2017 – by
EMERGO SUMMARY OF KEY POINTS:
- Switzerland’s Competent Authority has established grace periods for Swiss device manufacturers that must find new Notified Bodies to renew CE Mark certification.
- Swissmedic’s process resembles that announced by French Competent Authority ANSM in late 2016 for affected French manufacturers.
- To qualify for Swissmedic’s program, affected manufacturers must have already initiated certification renewal efforts with new Notified Body partners.
A second European Competent Authority, the Swiss Agency for Therapeutic Products (Swissmedic), has now addressed the burgeoning issue of medical device manufacturers whose CE Mark certifications may become jeopardized by Notified Bodies ceasing operations.
Swissmedic has reported that stricter inspections of Notified Bodies (NBs) by regulators has already reduced the number of European NBs offering medical device CE Mark certification services from roughly 80 to about 60; as a result, some manufacturers find themselves suddenly having to obtain new NB partners in order to certify or re-certify their devices, a process that can take as long as one year to complete.
“From a regulatory point of view, the validity of EC certificates during this transitional period has not been fully clarified,” states Swissmedic. “This raises the question of whether medical devices can continue to be placed on the market for the first time with affected EC certificates.”