Swiss Authorized Representative (CH-REP)

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Swiss Authorized Representative

Starting Point

  • 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 Authorised Representative (AR).

  • The respective Medical Device Ordinance (MedDO SR 812.213 version 01.07.2020) entered into force on 26.05.2021, the date of application of the Medical Device Regulation (EU) 2017/745.

  • Transition period for establishment of Swiss AR (including product labeling):
    • Until 31.12.2021: For MD class III, implantable MD class IIb and active implantable devices
    • Until 31.03.2022: For MD class IIa
    • Until 31.07.2022: For MD class I

Abstract of Obligation of Effectum CH-Rep AG
as Swiss Authorized Representative

Declaration of conformity and technical documentation

  • Review and assessment
  • Filing of copy and access to relevant information

Contact to competent authorities

  • Provide information and documentation necessary
  • Handle all requests between authority and manufacturer and ensure e.g. availability of samples and access to devices
  • Cooperate on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices

Complaint handling

immediate information about complaints and reports from healthcare professionals, patients and users

Person responsible for regulatory compliance

ensure that it has permanently and continuously at its disposal

Registration (as soon as applicable)

  • EUDAMED and Single Registration Number (SRN)
  • UDI core data elements


  • The authorised representative’s liability towards the manufacturer shall be limited to gross negligence and intent, except in the case of claims based on death or personal injury.
  • Customer must include Effectum CH-Rep AG in its liability insurance.

Next steps for

Next Steps

Next Steps

Why Effectum CH-Rep AG is a professional and reliable Swiss Authorized Representative (CH-REP)


Our standard services include outsourced Quality Management System and Legal Manufacturer – sharing risk has always been part of our business model

Sound and up-to-date knowledge about MDR/IVDR

In-house PRRC

Liability insurance


Experienced editors and reviewers of technical documentation

ISO 13485

Process lead from ideation until final submission

Senior Team of Regulatory Affairs Managers

# 3

Qualified to take over responsibility during product development and market phase, i.e. post market surveillance, vigilance, complaint handling, supplier management, etc.


Existing relations to Notified Body and national authorities

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