Swiss Rep for Medical Devices

Swiss authorized representative, Swiss Rep for Medical Devices

Swiss Rep

Swiss Authorized Representative

Since 26 May 2021, with the full application of the Medical Device Regulation MDR (EU) 2017/745 and in the absence of an institutional agreement reached, Switzerland is officially considered a “Third Country” for Europe. This means that European Manufacturers must designate a Swiss Authorized Representative and a Swiss Importer to export their products to Switzerland, in compliance with the Medical Device Ordinance (MedDo). Local Representation/Quote-stefan.jpg?preset=content

At the same time Swiss Manufacturers must appoint a European Authorized Representative to export their devices to Europe.

Responsibilities of a Swiss Rep

1) Check the CE certificate (if applicable), the DoC and technical documentation

2) Register the medical devices in the Swissmedic database

3) The Swiss Rep will act on behalf of the legal manufacturer with the Swiss competent authority
a) Responding to requests from Swissmedic and provide Swissmedic with information and
documentation necessary to demonstrate the conformity of a device.
b) Forward to the manufacturer any request by Swissmedic for samples or access to a device,
and ensure that Swissmedic receives the samples or has been given access to the device.
c) Cooperate with Swissmedic on any preventive or corrective action taken to eliminate or, if
not possible, mitigate the risks posed by devices.

4) The Swiss Rep will communicate any complaints and reports received from healthcare
professionals, patients and users about suspected incidents related to the registered
medical devices.

5) The Swiss legislation (MedDO) will continue to use the EU Medical Device Directive and Medical
Device Regulation.


Engaging Qserve 

1) Qserve's contracted partner is located in Switzerland, having employees on the ground who will have verified access to the Swissmedic database.

2) Qserve is an independent party, there is no conflict of interest between Qserve and the manufacturer. Distributors often work with several manufacturers, and sharing the details of the technical documentation can be a risk for the IP of the devices.

3) Respected group of experts
a) The Swiss Rep is the first point of contact for regulatory issues with the Swiss competent authorities.
Qserve and its partner have a knowledgeable team who will understand the communication they are
receiving. Distributors who are not authorized representatives may not have staff with regulatory
knowledge and may not understand the relevance of the communication.
b) As a Qserve customer, you will be made aware of any/all changes to the Swiss legislation, ensuring
that your business is minimally impacted.
c) Qserve’s strengths:
 • Diverse team that supports regulatory, clinical, and quality services
 • Support with Swiss regulation
 • Global footprint, local service

Interested in our Swiss Rep service?

We would like to tell you more about the possibilities that Qserve offers as a Regulatory Consultant.

Information Request

Free Webinar

Swiss Representative: All you need to know

Learn more about Swiss Representative. Join Stefan Menzl and guest speaker Angelina Hakim from QUNIQUE Group for a Free Webinar on Swiss Representative: All you need to Know.

Learning Objectives:

  • What is a Swiss Authorised Representative?
  • What are the duties of the Swiss Authorised Representative?
  • What can I do now?
  • When do foreign manufacturers need to take action?

Watch the Webinar