FAQs: Notification for the placing on the market of a medical device according to Art. 6 of the Medical Devices Ordinance (MedDO, SR 812.213)
1. Do all devices that are to be marketed in Switzerland have to be notified to Swissmedic according to Art. 6 of the Medical Devices Ordinance (MedDO, SR 812.213)? 2. Do Swiss manufacturers/authorised representatives have to provide notification of a device even if it is not to be marketed in Switzerland? 3. Why does Swissmedic not indicate individual product names on the acknowledgement of receipt for „IVD other“? 4. As of when will a fee be payable for notifying the placing on the market of medical devices according to Art. 6 MedDO? 5. Why are notifications for the placing on the market of medical devices according to Art. 6 MedDO subject to a fee of CHF 300 for each notification as of 1 January 2019? 6. For what notifications is a fee charged? 7. Do I have to pay CHF 300 for each individual device notified, or is it possible to notify several devices on one form? 8. Is there any change to the submission practice due to the introduction of fees? 9. Who is the invoice recipient? 10. How can I assign an invoice to a notification? 11. What is changing as a result of the revised European Regulations? 12. Do class I medical devices that are currently notified to Swissmedic according to Art. 6 MedDO need to be renotified on the basis of the MDR if a) the devices are still class I devices under MDR or b) the devices have a higher classification under MDR? 13. How will classical and active implantable medical devices that were derived from, or that incorporate, devitalised human tissue be treated in Switzerland in future under the revised European Regulations? 14. What happens after the switch to the European database for medical devices (EUDAMED)?
Last modification 20.05.2019