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Medical devices legal and regulatory blog

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Category: Recast

But weren’t they supposed to vote on it on the 14th?

Proposal to manage IVDR

The new EU AI regulation proposal, medical devices and IVDs

MDR date of application next month – and the book

Standardisation request for MDR and IVDR refused; now what?

The urgency with IVDs and the IVDR

Date of Entry into Force plus three years and a little bit

MDR date of application move: politically a done deal now

New MDCG guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions

MDR amendment proposal article 120 (3) oversight set to be fixed by Council

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