Swissmedic has decided to follow the harmonised European procedure.
Manufacturers based in Switzerland who are affected by EC certificates of this kind therefore have a maximum of 12 months (PoG) following the (partial or complete) de-designation of their former NB during which to restore the legal conformity of their product.
Within this period, Swissmedic will not take action against the continued placing on the market of medical devices bearing the identification number of the “old” NB provided that the following conditions are met in full:
- Product safety is ensured, i.e. the medical devices covered by the EC certificate represent no known or relevant risk
- The essential requirements continue to be met in full
- The manufacturer can demonstrate that the process of renewing the EC certificates of the affected products has been started with a new NB
- The manufacturer can produce at any time an overview of the affected products/EC certificates and their current status
To read more about this, please click here.