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?

Read Swiss Rep blog

Why Decomplix as your partner

  • Decomplix is experienced in taking on full regulatory responsibility for medical devices as part of its separate services as a legal manufacturer.
  • Decomplix has a complete ISO 13485 certified quality management system.
  • Decomplix’ customers benefit from an easy to use digital platform and a secure state-of-the-art IT infrastructure.
  • Decomplix stands by as a coach in compliance matters and as the customer’s close contact to Swiss authorities.

Decomplix offers the Swiss Rep services together with ISS AG, Integrated Scientific Services

ISS AG, Integrated Scientific Services is part of our strong network of best-in-class partners. The ISS team extends capacities as well as product-specific knowledge to Decomplix’ customers in the areas of medical device development, technical documentation, quality management, clinical and regulatory affairs.     www.iss-ag.ch