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).
  

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• 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.
  

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• 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

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 CH-Rep AG in its liability insurance.