Today Swissmedic released their official position regarding the EU MDR transition extension under Regulation 2023/607, available: HERE
Swissmedic confirmed they will implement the same transition extension into its legislation to ensure continued equivalence with the EU Regulations. However, they also advised that the Medical Device (MedDO) and IVD (IvDO) Ordinances will not be updated until Autumn 2023.
In the meantime, “Swissmedic will tolerate the placement of devices on the market in Switzerland which are covered by a valid certificate according to the MDR and IVDR amendments.”
Therefore, if the MDD/AIMDD CE Certificate expires before the Swiss regulations are updated, they may continue to be placed onto the Swiss market as long as they meet the criteria under the EU extension. Further, Swissmedic advised that manufacturers of expired CE Certificates do not need to request Swissmedic’s authorization as outlined in MDCG 2022-18 (i.e., authorizations under MDR Article 97).
Swissmedic also confirmed that they “will base its enforcement on the relevant EU interpretation documents.”
As always, Casus will keep you updated as new developments arise.
For more information on the MDR Transition Extension, please read: MDR Extension Published, Enters into Force Today