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UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

APHA weekly update (WC 22 Apr)

Please note this is an extract of the original bulletin. Check import risk categories, inspection rates and related rules for animals and animal products imported from non-EU countries to Great Britain Page summary: Import risk categories under the Border Target Operating Model (BTOM) for animals or animal products you’re importing from a non-EU country to Great Britain (England, Scotland and…

adminMay 1, 2024

UK Government Updates Regulatory Affairs Newsletter UK 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…

adminMay 1, 2024

DEFRA weekly update (WC 22 Apr)

Please note this is an extract of the original bulletin. Wet wipes containing plastic: proposed ban on the manufacture, supply and sale Page summary: The UK Government, Welsh Government, Scottish Government and the Department of Agriculture, Environment and Rural Affairs for Northern Ireland want your view on a proposed ban on the manufacture, supply and sale of wet wipes containing…

adminMay 1, 2024

UK Government Updates Regulatory Affairs Newsletter UK 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…

adminMay 1, 2024

HMRC weekly update (WC 22 Apr)

Please note this is an extract of the original bulletin. Search the register of customs agents and fast parcel operators Page summary: Find a customs agent or fast parcel operator to help you with import and export declarations. Change made: The list of customs agents has been updated with 1 addition and 2 amendments. Border Force customs offices list Page…

adminMay 1, 2024

Industry Newsletters Regulatory Affairs Newsletter Industry 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…

adminMay 1, 2024

FDA updates Regulatory Affairs Newsletter FDA 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…

adminMay 1, 2024

European Commission Updates Environmental Newsletter European Commission Updates Environmental Newsletter Archive European Commission Updates Regulatory Affairs Newsletter European Commission Updates Regulatory Affairs Newsletter Archive

EU Parliament votes on CLP revision and proposal on Microplastic Pellet Losses

On 23 April, the European Parliament voted on two files relevant to MedTech Europe from a chemicals angle: the CLP Regulation core revision and the Commission proposal for a Regulation on Microplastic Pellet Losses. 1. CLP Core Revision This is a file MedTech Europe engaged in over the last few years via public consultations and interviews with Commission consultants, with…

adminMay 1, 2024

EU parliament approves the final provisional agreement on the Packaging and Packaging Waste Regulation (PPWR)

On 24 April, the plenary of the European Parliament approved the final provisional agreement on the Packaging and Packaging Waste Regulation (PPWR). The EP’s endorsement of the following elements of the agreement reached with the Council: Article 6.11 and 6.12 (renumbered) – recyclability/recycling of scale: A material neutral approach is enacted for the following medtech specific derogation from newly introduces…

adminMay 1, 2024

UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive

HSE publications WC 22 Apr

HSE have published their latest bulletins: Biocides 25 April: EU active substance expiry date postponed Active substance expiry date postponed whilst the renewal evaluation is completed in the EU For reasons beyond the control of the applicant, the approval of the active substance/product type combination listed below was likely to expire before a decision could be taken on its renewal…

adminMay 1, 2024