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

DBT weekly update (WC 29 Apr)

Please note this is an extract of the original bulletin. Placing manufactured products on the market Page summary: Find out which standards and regulations apply to your product and how to make sure you follow the right procedures. Change made: Conformity assessment section updated with link to ‘Conformity assessment testing under mutual recognition or free trade agreements’ page. Notice to…
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May 8, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 22 Apr)

Please note this is an extract of the original bulletin. Spain: UK Science and Innovation Network Country Snapshot Page summary: A summary from UK Science and Innovation Network (SIN) on science and innovation in Spain including UK SIN priorities and successes. Change made: Summary fully reviewed and updated, Regulations: consumer connectable product security Page summary: Guidance for manufacturers, importers and…
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May 1, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 22 Apr)

Please note this is an extract of the original bulletin. REUL (Revocation and Reform) Act 2023 statutory instruments Page summary: On this page you will find the complete list of statutory instruments (SIs) which will be laid under the REUL (Revocation and Reform) Act 2023. Change made: The Health Claims (Revocation) Regulations 2024 SI added to the page under the…
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May 1, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 22 Apr)

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: Added: LNE-GMED UK Limited in-vitro medical devices scope. LNE-GMED UK Limited active implantable medical devices scope Notify MHRA about a clinical investigation for a medical…
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May 1, 2024
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

IMDRF publishes a new guidance document

The IMDRF have published a new guidance document "Principles of Labeling for Medical Devices and IVD Medical Devices" (IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2)). This document provides a globally harmonized labeling principles for medical devices, including in vitro diagnostic (IVD) medical devices, and support IMDRF/GRRP WG/N47 (Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices). This document…
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May 1, 2024
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 29 Apr)

FDA Takes Action to Help Ensure the Safety and Effectiveness of Laboratory Developed Tests Page Summary: On 29 April, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised…
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May 1, 2024
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