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European IVD Makers Continued to Face Regulatory Uncertainty Around IVDR, Brexit in 2022

A shortage of regulatory capacity continues to slow the implementation of the EU's In Vitro Diagnostic Regulation.

United kingdomNorthern irelandNoord hollandErik vollebregtPeter biedermannAnita tollerStephen leeRichard houlihanKec internationalEu medical device coordination groupEuropean commissionDrug administrationSwiss federal assemblySwiss federal councilUnited kingdom office for life sciencesHealthcare products regulatory agency

Switzerland: Software as a medical device

In its decision of 12 September 2022 (C-1256/2020), the Swiss Federal Administrative Court (FAC) confirmed that interpretive software that uses…

Chiara bolterSwiss federal administrative courtEu medical device coordination groupEuropean medical device directiveEuropean medical device regulationDevice coordination groupSwiss medical device ordinanceAw firmsAw updatesEgal updatesEgal developmentsAw developmentsEgal newslettersEgal current awarenessEgal advisersEgal advisors

Global Authorities Ramp Up Medical Device Cybersecurity Expectations: What Medical Device Companies Need to Know | Orrick, Herrington & Sutcliffe LLP

The last year has seen a multijurisdictional regulatory push for increased cybersecurity standards for medical devices. The new approaches, issued by regulatory authorities in the.

United statesUnited kingdomBruxelles capitaleUnited kingdom national health serviceSoftware bill of materialsParty procurementEu medical device coordination groupDrug administrationProduct development frameworkHealth insurance portabilityTelecommunications infrastructure billUnited kingdom national cyber security centreHerrington sutcliffeAccountability actProduct securityCyber resilience act

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