MEDIcept Insights

Guidance on IVDR Significant Changes

Guidance on IVDR Significant Changes

Medical devices are constantly changing and evolving to meet the needs of patients and healthcare professionals. The Medical Device Coordination Group (MDCG) has released a new guidance document, MDCG 2022-6, Guidance on significant changes regarding the transitional...

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EU to Delay Portions of the IVDR Rollout

The European Union had recently proposed doing what the medical device industry has been urging for years – delaying the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR) that is slated to replace the current In Vitro...

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