a) Only Swiss Manufacturer or CH-REP may file an application to Swissmedic.
b) Swissmedic checks the submitted documents exactly according to the following table of MDCG-2022-18. Therefore, study this table carefully and compile and submit the required documents according to this table structure.
In addition to the documents listed in the following table, Swiss manufacturer and CH-REPs should also provide the following information:
(i) details of the Swiss manufacturer or CH-REP: CHRN, name of company, address, PRRC and contact person.
(ii) list of devices affected by the certification gap including
-
- article number
- device name
- risk class acc. to MDD or AIMDD
- reference to corresponding MDD or AIMDD certificate(s)
- Reference to corresponding Declaration of conformity
(iii) disclosure on notification acc. to MDCG 2022-18 that have been submitted to EU/EEA competent authority by the manufacturer or its EC-REP.
(iv) disclosure of any measures according to Art. 94-97 MDR of EU/EEA competent authorities that have been communicated to the manufacturer, including refusal of periods acc. to MDCG 2022-18.