Here we will look back at the Swiss regulatory changes and announcements from 2022 and look forward to the important deadlines and anticipated announcements for 2023.

NOTE: The 2022 recap is not exhaustive; it includes the updates that may be interesting to a wide pool of manufacturers.

2022 Recap

More information on the below topics can be found in our: Swiss Regulatory Updates

January

• • The ‘Procurement of medical devices in health institutions’ guidance was updated. This document outlines that devices supplied directly by the manufacturer to a healthcare professional or facility are not considered ‘placed on the market’ and therefore, the manufacturer is not obligated to appoint a Swiss Authorized Representative. However, Swissmedic updated the guidance to clarify:
    • “healthcare professionals and institutions should usually procure products from a Swiss manufacturer or that have a Swiss authorised representative and only directly use products from abroad without a Swiss authorised representative in justified exceptional cases.”
      • i.e., while technically non-Swiss manufacturers can sell to Swiss healthcare professionals and institutions without appointing a Swiss Authorized Representative, Swissmedic strongly advises those professionals and facilities not to do so unless there is strong justification for it.

March

• • Class IIa and IIb non-implantable manufacturers’ deadline to appoint a Swiss Authorized Representative arrives: 31 March 2022
  • Swissmedic announces that it will implement its own EUDAMED-like medical device database (‘Swissdamed’), as it no longer has Competent Authority level access to EUDAMED.
  • Despite the lapsed Mutual Recognition Agreement with the EU, the Swiss Federal Council confirms it will implement the EU’s In Vitro Diagnostic Regulation (IVDR) into its national law (“IvDO”). The effective date to be the same as the IVDR’s date of application: 25 May 2022                          

May

• • Swissmedic formally announces that:
    • The provisions of the EU IVDR were transferred into a new Swiss ordinance on In vitro Diagnostic Medical Devices (IvDO)
    • It will implement the same IVDR progressive rollout dates as the EU
      • Class A IVDs must comply with the IVDR/IvDO on its date of application: 26 May 2022
      • Remaining device classes must comply according to the rollout schedule
    • A Swiss Authorized Representative will be required for foreign IVD manufacturers, with a transition period granted for products already on the market:
      • Class D – 31 December 2022
      • Class C/B – 31 March 2023
      • Class A – 31 July 2023
      • New manufacturers/newly CE Marked devices must appoint a Swiss AR prior to marketing the device and the above deadlines are not applicable
    • Swiss Importer obligations will apply for foreign products placed on the market

July

• • Class I manufacturers’ deadline to appoint a Swiss Authorized Representative arrives: 31 July 2022

September

• • Swissmedic announces more information about its registration database (“Swissdamed”):
    • It will launch sometime in 2023
    • It will consist of two modules:
      1. Economic Operator Registration
      2. Device Registration
    • Economic operators who already registered with Swissmedic will not need to register again in the new Economic Operator registration module

November

• • Swiss Parliament votes to allow US FDA devices onto the Swiss market. This was a political decision. The Swiss Federal Council did not support this decision and objected to the proposal. That said, in the end, the vote passed. As a result, the Swiss Federal Council has been instructed to place this allowance into the legislation.
    • No information available yet regarding when it will be implemented and if the allowance will cover all risk classes or only those that have FDA 510(k) clearance or approval.

December

• • Class D IVD manufacturers’ deadline to appoint a Swiss Authorized Representative arrives: 31 December 2022
  • The Liechtenstein Customs Treaty was updated to allow Liechtenstein-based companies to act as Swiss Authorized Representatives. Further, manufacturers and importers in Liechtenstein are exempt from having to appoint a Swiss Authorized Representative, though they must meet other obligations, such as obtaining a Swiss Single Registration Number (CHRN).

2023 Look Forward

Known Deadlines

• • By 31 March 2023:
    • Class B/C IVD manufacturers must appoint a Swiss Authorized Representative (applicable for both IVDR and IVDD CE Marked devices).
  • By 26 May 2023:
    • UDI Carrier is required on labeling for MDR CE Marked Class IIa/IIb and IVDR CE Marked Class D devices & UDI Direct Marking is required for MDR CE marked reusable implantable and Class III devices.
  • By 31 July 2023:
    • MDR Class I devices must apply the Swiss Authorized Representative’s information to the device labeling
      • Prior to that date the Swiss Authorized Representative may be identified on labeling or in ‘a document accompanying the device’, which includes documentation such as a delivery note, customs documentation, invoice, or instructions for use.
    • Class A IVD manufacturers must appoint a Swiss Authorized Representative (applicable to both IVDR and IVDD CE Marked devices).

Expected Announcements

• • Deadlines to submit medical device registrations into the new Swissdamed registration database.
  • Timeframe regarding when the legislation will be amended to allow FDA devices onto the market – and which classes of devices will be eligible.
  • If the Swiss Federal Council will adopt the same MDR ‘delay’ being proposed by the EU Council.
    • EU Council’s proposal on the MDR delay is expected in early 2023 and would push the deadline from 2024 to 2027 – 2028 depending on the device classification.