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

European Commission study on availability of medical devices on the EU market

European Commission’s Directorate-General for Health and Food Safety (DG SANTE) has contracted Austrian National Public Health Institute (Gesundheit Österreich GmbH / GÖG) to launch a study for manufacturers of medical devices and in-vitro diagnostics and authorized representatives. The aim of the study is to collect information on the transition of devices to medical devices and in-vitro diagnostic medical devices regulations.…
admin
December 8, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

New EU Reference Labs designated for Class D IVD devices

The European Commission have designated five EU reference laboratories for high-risk in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2023/2713. These labs will enhance conformity assessments and advisory tasks for devices related to critical health areas like hepatitis, retroviruses, bacterial agents and life-threatening respiratory viruses. The labs are expected to start testing IVDs from October 1, 2024, for tasks…
admin
December 8, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Draft statutory instrument published in respect of Northern Ireland

The Department of Health and Social Care have laid a new draft statutory instrument before the House of Commons and the House of Lords on 14 November. Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023 (SI 2023) makes provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/746 of the European Parliament. BIVDA have provided…
admin
December 8, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 20 Nov)

Please note this is an extract of the original bulletin. International Recognition Procedure* Page summary: How to use this new procedure for medicines licensing applications. Change made: Added guidance on the Eligibility Checker and submitting your Marketing Authorisation application, IRP Product Lifecycle & eCTD guidance for MAs and Lifecycle. MHRA fees* Page summary: Fees payable to the MHRA for 2023…
admin
December 1, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 20 Nov)

Please note this is an extract of the original bulletin. Biggest prostate cancer screening trial in decades to start in UK Page summary: The trial will use innovative screening methods like an MRI scan and see hundreds of thousands of men across the country participating Change made: First published. Government response to the review into commercial clinical trials Page summary:…
admin
December 1, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 20 Nov)

Please note this is an extract of the original bulletin. Smarter regulation Page summary: This page sets out how the UK government’s smarter regulation programme seeks to reduce burdens on businesses and promote innovation and growth. Change made: Retained EU employment law reforms added to the page under the “Policy Decisions” section. Notice to exporters 2023/22: Export Control Joint Unit…
admin
December 1, 2023
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