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Wednesday, March 19th 2025

News

4th revision of MDCG 2020-16 guidance on the rules for classification of in vitro diagnostic medical devices under Regulation (EU) 2017/746

The Medical Device Coordination Group has just published the 4th revision of the MDCG 2020-16 guidance on the classification rules (...)

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Thursday, October 31st 2024

News

Updated Draft Statutory Instrument for Post-Market Surveillance: Gap Analysis

A new draft statutory instrument for post-marketing surveillance has been published. Our team has conducted a detailed gap analysis to (...)

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