Medical devices

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IG-NB and team NB jointly publish AI questionnaire for medical devices

The Industry Group of Notified Bodies (IG-NB) and Team NB have collaboratively released a questionnaire addressing artificial intelligence in medical devices. This document, developed in response to MDGG 2022-14 requests, primarily focuses on the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), as well as the Medical Device Software (MDSW) guidance from the Medical Device Coordination Group (MDCG). While the questionnaire does not fully incorporate the specific requirements of the AI Regulation 2024/1689, it acknowledges the significant overlap between this regulation and existing regulatory frameworks for software and AI in medical devices. A comprehensive revision is planned to fully integrate the AI Regulation's requirements in the future.

EMA revises good manufacturing and distribution practices Q&A guidance

The EMA has revised its guidance on good manufacturing and distribution practices (GMP/GDP). A new question and answer has been added to a section about an annex on certification by a qualified person and batch release. The new question asks how the traceability of the supply chain of the active substance and medicinal product should be documented to support the qualified person batch certification and release.

ABHI proposes HealthTech-Focused reforms in industrial strategy response

The Association of British HealthTech Industries (ABHI) has submitted a comprehensive response to the UK government's Industrial Strategy Green Paper, focusing on the HealthTech sector. ABHI has proposed significant reforms to regulatory processes, including recognition of approvals from trusted jurisdictions, and improvements to NHS procurement and adoption pathways. The association has also highlighted barriers to investment and growth, suggesting measures to enhance data sharing, infrastructure, and alignment with devolved governments' strategies. ABHI emphasizes the need for a tailored approach to HealthTech within the broader Life Sciences sector, advocating for dedicated representation and policy considerations to unlock the sector's full potential for economic growth and healthcare innovation.

Life Sciences weekly highlights—28 November 2024

This week's edition of Life Sciences weekly highlights includes a news analysis by Taylor Wessing on the impact of the EU AI Act on medical device regulation and Law360 analysis of the CAT's judgment reinstating almost identical fines of £69m against Pfizer and Flynn Pharma for abusing its market dominance and charging the NHS excessive prices for a key epilepsy treatment but with differing reasoning from the CMA. Also included, is news that the European Commission provided guidance on the gradual roll-out of EUDAMED and published its findings from its evaluation of Commission Regulation (EU) 316/2014 (the Technology Transfer Block Exemption Regulation or TTBER) and news that the European pharmaceutical industry has called for urgent policy reforms to support Europe’s biopharma SMEs.

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