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
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 onboarding
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
Experienced editors and reviewers of technical documentation
Process lead from ideation until final submission
Senior Team of Regulatory Affairs Managers
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