Swiss Authorized Representative

Swiss Authorized Representative

Swiss Authorized Representative

Swiss Authorized Representative for foreign medical device manufacturers.

As of 26 May 2021, Switzerland has revised its medical device legislation to align with the EU Medical Device Regulation (EU MDR 2017/745). To sell CE-marked devices in Switzerland. Manufacturers located outside of Switzerland will need a Swiss Authorized Representative (CH-REP) under the Swiss Medical Device Ordinance (MedDO, RS 812.213) and the Ordinance on In-Vitro Diagnostic Medical Devices (IvDO).

Enable the legal marketing of products.

Ensure compliance with the registration rules.

Ensure that the declaration of conformity and technical documentation have been drafted in accordance with the law.

Communication with authorities (Swissmedic).

Service

  • Ensure compliance with MedDO/IvDO requirements
  • Provide copies of the technical documentation, declaration of conformity (DoC), relevant documentation, and product samples to the swiss competent authority (swissmedic), upon request
  • Participating in Swissmedic’s preventive and corrective actions during audits and/or requests for product samples
  • Providing Swissmedic with reports regarding serious incidents, Field Safety Corrective Actions (FSCAs), and Trend Reports
Contact us for more!

Swiss Authorized Representative for foreign medical device manufacturers.

As of 26 May 2021, Switzerland has revised its medical device legislation to align with the EU Medical Device Regulation (EU MDR 2017/745). To sell CE-marked devices in Switzerland. Manufacturers located outside of Switzerland will need a Swiss Authorized Representative (CH-REP) under the Swiss Medical Device Ordinance (MedDO, RS 812.213) and the Ordinance on In-Vitro Diagnostic Medical Devices (IvDO).

Enable the legal marketing of products.

Ensure compliance with the registration rules.

Ensure that the declaration of conformity and technical documentation have been drafted in accordance with the law.

Communication with authorities (Swissmedic).

Service

  • Ensure compliance with MedDO/IvDO requirements
  • Provide copies of the technical documentation, declaration of conformity (DoC), relevant documentation, and product samples to the swiss competent authority (swissmedic), upon request
  • Participating in Swissmedic’s preventive and corrective actions during audits and/or requests for product samples
  • Providing Swissmedic with reports regarding serious incidents, Field Safety Corrective Actions (FSCAs), and Trend Reports
Contact us for more!

1/7

Define the products for
CH Market.

.

2/7

Type and number of
products .

3/7

Existing
documents.

4/7

Extend
documentation.

5/7

Set up processes, implement measures.

6/7

Set up a collaboration
agreement.

7/7

Register as an authorized
representative agreement.

Ready?

Start the conversation

Understand the scope

Receive a proposal

Get access to Switzerland

Ready?

Start the
conversation

Understand the
scope

Receive a
proposal

Get access to Switzerland

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