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UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 01 Jul)

Please note this is an extract of the original bulletin. Medical devices: UK approved bodies* Page summary: UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Change made: Updated ‘DEKRA Certification UK Ltd medical devices scope’. *Note: IVD devices are not in scope Medical devices given exceptional use authorisations during the COVID-19 pandemic…
admin
July 10, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 01 Jul)

Please note this is an extract of the original bulletin. UK Trade Tariff: duty suspensions and autonomous tariff quotas Page summary: Temporary duty suspensions and autonomous tariff quotas for importing goods into the UK. Change made: Guidance updated to reflect closing of new suspensions window that ran from 8 May 2024 to 3 July 2024. UK-Australia FTA Joint Committee Statement…
admin
July 10, 2024
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…
admin
July 10, 2024
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 01 Jul)

Small Entity Compliance Guide: Laboratory Developed Tests The U.S. Food and Drug Administration (FDA) have issued a Small Entity Compliance Guide (SECG) to assist small entities in complying with FDA regulations as they apply to in vitro diagnostic (IVD) products, including laboratory developed tests (LDTs). The LDT final rule published on May 6, 2024, amends the FDA’s regulations to make…
admin
July 10, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

Regulation (EU) 2024/1860 published on Official Journal of the European Union

On 09 July, the Regulation (EU) 2024/1860 amending the EU MDR and EU IVDR has been published in the Official Journal of the European Union (OJEU). This amends the EU MDR and EU IVDR by: Further extending the transition period for certain IVDs as long as they meet certain conditions. These devices can benefit from the following transitional period: 31…
admin
July 10, 2024
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