Swissmedic hosted an IvDO/IVDR seminar in early November 2022.

The seminar was conducted as a live stream and not recorded. However, the presentation materials are available: HERE

Below are some highlights for IVD manufacturers to consider.

Status of Mutual Recognition Agreement (MRA) with Europe

• • Confirmed continued lack of Agreement with the EU
  • Some of the mitigating measures put into place:
    • Swissmedic continues to recognize EU Notified Bodies, even though Europe does not recognize Swiss Notified Bodies
    • Swissmedic continues to recognize (and require) European CE Marking
    • Swissmedic has developed its own Single Registration Number (CHRN), separate from the EUDAMED Single Registration Number (SRN)
    • Will develop its own ‘EUDAMED’-like registration database called ‘Swissdamed’
    • Requires appointment of a Swiss Authorized Representative (CH-REP)
  • Some of the issues due to lack of MRA
    • Numerous references in Swiss law to the IVDR and yet the MRA is no longer applicable, and now requires legal interpretation in some areas
    • Swissmedic is receiving thousands of questions from economic operators

Read: What is a CHRN?

IvDO/IVDR Compliance

• • The Swiss in vitro diagnostic device ordinance (IvDO) heavily references the IVDR
  • The seminar materials reflect this. For example:
    • It recognizes the same IVDD legacy device transition period as the IVDR
    • It provides the same deadlines to affix Unique Device Identification (UDI) to products

For more information about the IvDO, please read: Switzerland Adopts IvDO/IVDR

Struggling to keep up with all the looming deadlines in Switzerland, Europe, and the UK? Download our: Important Dates Chart

‘Swissdamed’ registration database

• • Confirmed the 2023 “go-live” date
  • Confirmed only the Actor and UDI/Device Registration modules are currently planned for Swissdamed, unlike EUDAMED which plans additional modules on Notified Bodies & Certificates, Clinical investigations and performance studies, Vigilance and post-market surveillance, and Market Surveillance
  • Appears that only Swiss-based economic operators will have access to register, i.e., most likely the Swiss Authorized Representative will register the foreign manufacturer’s devices for them, similar to the UK Responsible Person’s requirement to register devices for foreign manufacturers they represent

Read: Switzerland Registration Database (Swissdamed)

Authorized Representatives (CH-REPs)

• • Jointly responsible with the manufacturer for device general safety and performance requirements
  • Responsible for adverse event reporting, FSCAs and trend reporting, on the manufacturer’s behalf
  • Must obtain a CHRN, i.e., be registered with Swissmedic
  • Their Person Responsible for Regulatory Compliance (PRRC) does not need to be domiciled in Switzerland
  • There is a transition period to appoint a CH-REP*
    • Class D – 31 December 2022
    • Class C/B – 31 March 2023
    • Class A (sterile and non-sterile) – 31 July 2023
  • Devices that do not qualify for the transition period, must have a CH-REP appointed prior to marketing

*Both IVDD and IVDR CE marked devices require a CH-REP. The classification is based on what the device classification will be under the IVDR. In order to qualify for the transition period, the device must already have been on the European market prior to the IVDR’s date of application (26 May 2022). Any IVDs newly placed onto the market after that date do not qualify for the transition period.

Read: Role of the Swiss Authorized Representative

Importers

• • Importers are obligated to confirm that the device is:
    • CE marked
    • Declaration of conformity has been signed
    • Manufacturer is identified
    • Swiss Authorized Representative has been appointed
    • UDI is applied where required
    • Device and IFU are labeled in the three national languages required for Switzerland: German, French, Italian
  • Importer is required to act as the ‘gatekeeper’ for the Swiss market, and where there is any doubt about its conformity, may not place the device on the market
  • Importer is required to have proper device traceability measures in place
  • Obtain a CHRN, i.e., be registered with Swissmedic
  • Goods are ‘placed onto market’ by the Swiss importer to a Swiss customer, and not by the foreign manufacturer to the importer
    • This distinction is important because there are various deadlines by which products may no longer be ‘placed onto the market’, such as MDD legacy devices after 26 May 2024; or by which a Swiss Authorized Representative must be identified, such as 31 March 2023 for Class B/C IVDs. If the products are sitting in an importer’s warehouse, it is not yet considered placed on the market, even though the manufacturer may have transferred ownership of the product to the Swiss importer.

Distributors

• • Similar requirements as the importer to confirm the device has been CE Marked, have traceability measures in place, etc.
  • Additionally required to confirm that the importer is appropriately identified

If you have any questions about the process to market in Switzerland, please contact us for support.