EU IVDR Amending Regulation Published And Staggered Grace Periods Now Official
The text amending the IVD Regulation, taking the pressure of the entire sector, has now been officially published. But clarification is needed regarding timelines for compliance for in-house IVDs.
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The EU’s full implementation of the In Vitro Diagnostic Regulation on 26 May has put the Swiss IVD industry on a "third country" footing with the EU, as happened in 2021 for medical devices. The two parties’ mutual recognition agreement for all medtech products has ceased to apply. A renewed MRA is not likely for several years.
The European Commission has published the first draft Implementing Regulation for common specifications in the context of the IVDR. There is an unexpected two-year gap until its requirements will be mandatory.
The European Commission has injected an increased sense of urgency into its updated IVDR implementation plan and is creating a feedback loop to help direct resources where most needed.