Validity of EC certificates if the competent Conformity Assessment Body ceases its activities (Art. 12a MedDO, conformity assessment process in accordance with Annex 3 MedDO)
This information sheet replaces the publication “Swissmedic’s approach to handling EC certificates for medical devices” dated 22 December 2016.
Information on the requirement criteria to be observed by dispensing points, on medical devices for the public and on the issuing of medical devices on a self-serve basis can be found here (in German):
In connection with preventive market surveillance, Swissmedic has reminded more than 100 Swiss webshops of their responsibility as regards professional advice, product surveillance, operating prerequisites and documents that the dispensing point must produce for the authorities on request. The letter to webshops can be found here (in German):