Swiss Authorized Representative

Your access to Switzerland

We make it possible for you to sell your medical devices in Switzerland and we offer you the legal infrastructure to do so.
Your Goal

Selling medical devices in Switzerland

Manufacturers domiciled outside Switzerland (who are not covered by any third country agreements and / or agreement on the mutual recognition of conformity assessments) must designate an Authorized Representative (AR).

The Medical Device Ordinance (MedDO SR 812.213 version 01.07.2020) entered into force on 26.05.2021, which is also the date of application of the Medical Device Regulation (EU) 2017/745. All transitional periods have expired, and a Swiss AR is required for all MDD/MDR products.

The Ordinance on In Vitro Diagnostic Medical Devices (IvDO) is in force since 26.05.2022. The same date as the date of application of the IVDR in the EU. The following transitional periods for designating a Swiss AR are in place:

31.12.2022: Class D
31.03.2023: class B and C
31.07.2023: Class A

Our Services

Our tasks as your Swiss Authorized Representative (excerpt)

  • Ensuring compliance with Swiss registration requirements
  • Collaborating with Swissmedic on preventive and corrective measures during audits and/or requests for product samples or access to devices
  • To provide a Person Responsible for Regulatoy Compliance (PRRC)
  • Guaranteed access to a copy of the technical documentation
  • Reporting of incidents and complaints

Why do you need a CH-REP

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Your Benefit

Why Effectum CH-REP AG is a professional and reliable partner

Experience in building and maintaining Quality Management Systems for Medical Devices according to ISO standards
The sharing of risk is part of our business model, as we act as Legal Manufacturer on behalf of our customers.

Qualified in the handling of product registrations, as this is part of our standard service offering for existing customers.

A dedicated and highly motivated team with Senior Experts, who have gained sound MedTech knowledge in start-up’s, SME’s and global players.

From your request until Swiss market access

4 steps to appointing a Swiss Authorized Representative

Step 1.
Offer
You receive an offer from us

Following your request and the most important product information, you will receive a proposal.

Step 2.
NDA
Exchange of confidential information

If you are interested in collaborating with us, we will sign a non-disclosure agreement. You will subsequently receive our contract proposal. At the same time, we would, if needed, like to take a look at some selected contents of your technical documentation.

Step 3.
Review
Review of the technical documentation

Once the parameters of the collaboration are fixed, we review the complete technical documentation.

Step 4.
Collaboration
Contract

After signing the contract, we register you as a client with Swissmedic.

Effectum CH-REP

A company of Effectum Medical - Your start-up to market

Effectum Medical facilitates an efficient, accelerated market access for Medtech innovators by offering a maintained plug-and-play QMS and acting as legal manufacturer.
Ulrike Neuberger

Your contact person

We would be delighted to be your CH-REP!

Why Effectum CH-Rep AG is a professional and reliable partner.

Quality Management Systems

Zu unseren Standarddienstleistungen gehören ausgelagerte Qualitätsmanagementsysteme und legale Hersteller - Risikoverteilung war schon immer Teil unseres Geschäftsmodells
Fundiertes und aktuelles Wissen über MDR/IVDR
Eigenes PRRC
Haftpflichtversicherung

Erfahrung

Erfahrene Redakteure und Prüfer von technischer Dokumentation
ISO 13485
Prozessleitung von der Ideenfindung bis zur endgültigen Einreichung
Leitendes Team von Regulatory Affairs Managern

Verantwortung

Qualifiziert für die Übernahme von Verantwortung während der Produktentwicklung und der Marktphase, d. h. Überwachung nach dem Inverkehrbringen, Vigilanz, Bearbeitung von Beschwerden, Lieferantenmanagement usw.

Beziehungen

Bestehende Beziehungen zu benannten Stellen und nationalen Behörden

Request a quote

Please let us know how many Technical Documentations and EMDN codes (or GMDN / UMDNS codes) you have.

(Please note that Effectum CH-Rep AG accepts a mandate as the Swiss Authorized Representative for Class III / IVD List/Class D products only in exceptional cases upon thorough assessment of each request.)
The customer must include Effectum CH-Rep AG in its liability insurance. Effectum CH-Rep AG does not guarantee the acceptance of the mandate. Since the Swiss Authorised Representative is jointly liable with the manufacturer for defective products, Effectum CH-Rep AG makes the acceptance of the Swiss Rep mandate dependent on a preliminary verification of the conformity of the medical device, which includes the verification of the technical documentation. We will use your contact details to contact you directly to discuss possible cooperation opportunities now or in the future.

Please let us know how many Technical Documentations and EMDN codes (or GMDN / UMDNS codes) you have.

(Please note that Effectum CH-Rep AG accepts a mandate as the Swiss Authorized Representative for Class III / IVD List/Class D products only in exceptional cases upon thorough assessment of each request.)
The customer must include Effectum CH-Rep AG in its liability insurance. Effectum CH-Rep AG does not guarantee the acceptance of the mandate. Since the Swiss Authorised Representative is jointly liable with the manufacturer for defective products, Effectum CH-Rep AG makes the acceptance of the Swiss Rep mandate dependent on a preliminary verification of the conformity of the medical device, which includes the verification of the technical documentation. We will use your contact details to contact you directly to discuss possible cooperation opportunities now or in the future.