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European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

MDCG guidance on the classification rules for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746

On 08 July, the Medical Device Coordination Group (MDCG) published MDCG 2020-16 Rev. 3 guidance on "the classification rules for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746". This document provides updates from the previous revision released in February 2023. These include: Addition of ‘kit’ definition Revision of examples for Rule 3(a) and Rule 6 Revision of Rule…
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July 10, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

EU Harmonisation of standards update

The European Commission's Directorate-General presented at the Medical Device Coordination Group (MDCG) – Subgroup meeting on Standards, held on 12 June 2023. The presentation and the meeting minutes will be published in the Register of Commission Expert Groups and Other Similar Entities, once approved by the members.
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June 16, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

MDCG guidance schedule

The MDCG have published their latest ongoing guidance update. The following IVDR-related documents are included in this list: Notified bodies Q&A on requirements notified bodies – update of MDCG 2019-6 (Permanent work item, no estimated date) Standards Updates of guidance document MDCG 2021-5 on standardisation for medical devices (Estimated Q2 2023) Post-market surveillance and vigilance Guidance on Post-Market Surveillance requirements (Estimated Q2…
admin
March 17, 2023
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