EU 2024/1860 Swissmedic Updates for IVD Supply in Switzerland

On 9th July 2024 (with an adoption date of 13th June 2024), Amendment Regulation EU 2024/1860 came into effect with regards to EUDAMED, the obligation to inform in case of interruption or discontinuation of supply and transitional provisions for certain IVD’s. The EU has decided to extend the transition periods under certain conditions to minimize the risk of supply bottlenecks for IVD’s.

How Will the EU 2024/1860 Swissmedic Updates Impact IVD Supply in Switzerland?

Swissmedic is proactively enforcing the regulation amendment in alignment with the EU with the Swiss Federal Council announcement on 14th August, 2024, the need to implement similar measures in Switzerland to prevent supply issues of IVDs in Switzerland during the transitional phase. This involves extending the validity of certain certificates under the old legislation to 2027/2028/2029 (depending on classification). The simplified labeling requirements for certain IVD’s are to be continued indefinitely because it facilitates the sale of certain IVDs in the Swiss market and contributes to security of supply.

What Do the Upcoming MedDO and IvDO Amendments Mean for IVD Compliance?

The obligation to register products as already outlined in the MedDO and IvDO will become effective in 2026, with amendments to these ordinances expected in autumn 2024. Swissmedic will tolerate the conditions for extending the validity for IVD device certificates issued under Directive 98/79 EC that expired before July 9, 2024, or will expire after, based on the conditions set by the EU-IVDR amendment. Swissmedic’s enforcement will follow EU interpretation documents and, as the market surveillance authority in Switzerland, it retains the right to order corrective measures if necessary to protect health.

You can read the full announcement here, and here in German.

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If you have any questions about the EU 2024/1860 Swissmedic role in IVD supply & compliance or need regulatory help in bringing your IVD to the Swiss market, contact us so we can help you.

Learn how MedEnvoy can assist you:

• • Swiss Authorized Representative
  • Swiss Regulatory Importer
  • CE Marking Compliance Consulting
  • EUDAMED Registration