Swiss AR Deadline: Class A IVDsSwiss AR Deadline: Class A IVDsSwiss AR Deadline: Class A IVDsSwiss AR Deadline: Class A IVDs
  • Home
  • Services
    • Europe
      • Steps to Market
      • Authorized Representation
      • MDR CE Marking
      • IVDR CE Marking
    • United Kingdom
      • Steps to Market
      • Responsible Person
      • Device Registration
      • UKCA Marking
    • Switzerland
      • Steps to Market
      • Authorized Representative
      • Device Registration
  • Regulatory Updates
  • Resources
    • Frequently Asked Questions (FAQs)
    • Knowledge Center
    • Market Snapshots
    • Regulations & Guidance Documents
    • Tools & Templates
  • About Us
  • Contact Us
✕
Original UKCA Marking Deadline
May 11, 2023
EUDAMED Expected to be Fully Functional
May 11, 2023

Swiss AR Deadline: Class A IVDs

May 11, 2023

Class A IVD device manufacturers must have a Swiss Authorized Representative (AR) appointed in order to continue marketing in Switzerland.

 

IVDR not intended for self-testing: the Swiss AR (“CH-REP”) must be identified on the device label or in a document accompanying the device until 31 March 2025. Starting 1 April 2025, the CH-REP must be identified on the label.

 

IVDR devices already on the Swiss market before 26 May 2022 have until 31 July 2023 to appoint and add the CH-REP to the labeling. IVDR devices newly placed onto the market after 26 May 2022 must immediately identify the CH-REP on the label.

 

IVDD already marketed in Switzerland before 26 May 2022: the Swiss AR (“CH-REP”) must be identified on the device label, the instructions for use, or in a document accompanying the device. The deadline to appoint and identify the CH-REP is by 31 July 2023.

 

IVDD newly marketed in Switzerland after 26 May 2022: the Swiss AR (“CH-REP”) must be identified on the device label or the instructions for use. The deadline is as soon as the manufacturer begins marking the device in Switzerland. 

Share
© 2024 Casus Consulting LLC | All Rights Reserved

      Regulatory Newsletter

      Name(Required)
      Subscription Confirmation(Required)
      This field is for validation purposes and should be left unchanged.
      Newsletter Sign-up
      Close
      Manage Cookie Consent
      To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
      Functional Always active
      The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
      Preferences
      The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
      Statistics
      The technical storage or access that is used exclusively for statistical purposes. The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
      Marketing
      The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.
      Manage options Manage services Manage {vendor_count} vendors Read more about these purposes
      View preferences
      {title} {title} {title}