Swiss Authorized Representative

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 Medical 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

Insurance

  • 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 Medical in its liability insurance.

Next steps for
onboarding

nesxt steps

 

Order a quote
for Swiss Authorized Representative (Swiss Rep)

We are kindly requesting some more information from you.

Company and contact person

Company Details

Product

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

Number of EMDN codes

(Please note that Effectum Medical accepts mandate as the Swiss Authorized Representative for Class III / IVD List/Class D products only in exceptional cases upon thorough assessment of each request.)
Click or drag a file to this area to upload.
Click or drag a file to this area to upload.

Please note

Customer must include Effectum Medical in its liability insurance. Effectum Medical does not guarantee the acceptance of the mandate. Since the Swiss Authorised Representative is jointly liable with the manufacturer for defective products, Effectum Medical 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.

Why Effectum Medical is a professional and reliable Swiss Authorized Representative

#1

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

#2

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.

#4

Existing relations to Notified Body and national authorities

For more information
please contact us