The Swiss Agency for Therapeutic Products (Swissmedic) announced that it will allow orphaned manufacturers whose Notified Bodies have ceased operation to continue marketing their devices, subject to certain conditions.
EU regulators are implementing stop-gap measures to ensure continued access to the EU market for medical devices with EC certificates granted by Notified Bodies that are no longer operating due to more stringent requirements under the European Medical Device Regulations. The Swissmedic announcement follows a similar announcement by France’s National Agency for the Safety of Medicines and Health Products ().
Swissmedic said that for up to 12 months following the partial or complete de-designation of their former Notified Bodies, manufacturers may continue to market devices bearing the identification number of the previous Notified Body if product safety is ensured and a new Notified Body has begun renewing the CE certificate.
The number of qualified Notified Bodies has dropped from more than 80 to fewer than 60, and is expected to decrease even more, Swissmedic said. This has led to about 3,000 EC certificates not being monitored by a Notified Body.