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Weekly Regulatory Updates/Resources

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November Newsletter

EUROPEAN UNION (EU) EU guidance on reference laboratories for IVD medical devices | 30 November 2022 EU Commission has published new guidance for candidate reference laboratories in the In vitro diagnostic medical devices field. The document guides laboratories...

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October Newsletter 2022

EUROPEAN UNION (EU) Guidance on EU Authorized Representatives | 31 October 2022 Medical Device Coordination Group has updated its guidance on Authorized Representatives under MDR 2017/745 and IVDR 2017/746. Under both MDR and IVDR, it is a requirement for...

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September Newsletter 2022

EUROPEAN UNION (EU) Notified Bodies Position paper on application of hybrid audits for QMS assessments under MDR and IVDR|26 September 2022 The latest position paper discusses the need for hybrid audits instead of the traditional on-site audits which were previously...

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