Swiss Authorised Representative
Keep market access in Switzerland
for your medical device
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. Under this revised version of the Swiss Medical Device Ordinance (MedDO, RS 812.213), manufacturers located outside of Switzerland need 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.
Per the definition in the revised MedDO, a Swiss Authorised Representative corresponds to: “any natural or legal person established within Switzerland who has received a written mandate from a manufacturer located in another country to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligation under this Ordinance”. Upon acceptance of the written mandate, the Swiss Rep becomes the representative of the foreign manufacturer before the Swiss competent authority (Swissmedic), and is jointly liable with the manufacturer for defective products.
Decomplix offers Swiss Rep services, including regulatory support for your understanding of the applicable requirements (e.g., labeling, documents to be adapted) for a fixed package price, graded according to device risk class.
In full compliance with the revised MedDO, Decomplix services as Swiss Rep include:
- Ensuring compliance with registration requirements in Switzerland under the MedDO.
- Verifying that the device labeling fulfils the requirements in Switzerland.
- Keeping available a copy of the technical documentation and declarations of conformity for Swissmedic.
- Cooperating with Swissmedic on preventive and corrective actions during audits and/or requests for product samples.
- Ensuring vigilance duties for incidents and FSCA.
Insecurity in Swiss-market access
What is the problem? For whom? Which options are possible? When do foreign manufacturers need to take action?
