Swiss Authorised Representative (SAR)
Switzerland has revised its medical device legislation to align with the EU MDR (Reg. (EU) No. 2017/745) to have it apply simultaneously, on 26 May 2021 hence Switzerland has been considered as a third country status to the EU.
Under this revised version of the Swiss Medical Device Ordinance (MedDO, RS 812.213), manufacturers located outside of Switzerland are required to appoint a Swiss Authorised Representative (Swiss Rep) to sell their CE-marked devices in Switzerland. The absence of an updated Mutual Recognition Agreement between Switzerland and the EU to cover the EU MDR means that medical device manufacturers established in EU/EFTA countries also need a Swiss Rep under the revised MedDO.
As mutual recognition of conformity assessment procedures no longer appliesforeign manufacturers of medical devices in Switzerland must appoint an “Swiss Authorised Representative” (SAR).
A SAR is a natural or legal person established in Switzerland who is mandated in writing by a manufacturer abroad to perform certain tasks on his behalf in fulfilment of the manufacturer’s obligations arising from this Ordinance.
In order to simplify the process International Associates Limited has and agreement with CH-Rep.com to act as the SAR.
Manufacturers wishing to place product on the UK, EU and Swiss market can do so using as single point of contact who will manage all the technical file reviews and registration requirements.
Guidance on the regulations for Switzerland here
Changing your Authorised Representative.
Changing your Authorised Representative is a fairly straightforward process. First of all, this change should appear in the agreement between the manufacturer and the Authorized Representative (Outgoing and incoming).
To be compliant, the manufacturer should address the following aspects:
The date of termination of the outgoing Authorized Representative and the date of start of the incoming one.
The date until which the manufacturer can show the outgoing AR on the information or promotional material.
The transfer of documents, including confidentiality aspects and property rights
The obligation to the outgoing Authorized Representative to send to the manufacturer or incoming Authorized Representative, any complaints or reports from healthcare professionals and patients or users about suspected incidents related to the device for which it has been designated.