Any natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark. (Art. 4 MedDO)
Obligations: Art. 46 to 50 MedDO
Any natural or legal person established within Switzerland that places a device from abroad on the Swiss market.
Obligations: art. 53 MedDO
Any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the Swiss market, up until the point of putting into service.
Obligations: art. 54 MedDO
Authorised representative (Switzerland)
Any natural or legal person established within Switzerland who has received and accepted a written mandate from a manufacturer, located outside Switzerland, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under the Medical devices ordinance.
Obligations and mandate: art. 51-52 MedDO
If the manufacturer is not established within Switzerland, its devices may only be placed on the market if it has appointed an authorised representative in Switzerland.
If the manufacturer is established in an EU or EEA state or has an authorized representative in an EU or EEA state, the timelines in accordance with Art. 104 MedDO apply.
You can find further information on the Swiss authorised representative (CH-REP) here: Swiss authorised representative (CH-REP).
Registration of economic operators
Economic operators are registered according to Art. 55 of MedDO.
Further information on SRN and CHRN can be found on our website: Unique identification number according to Art. 55 MedDO (CHRN – Swiss Single Registration Number)
The registration responsibilities for manufacturers, authorised representatives and importers according to EU-MDR are detailed in Article 31 EU-MDR.