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ECHA weekly update (WC 08 May)

ECHA has published their latest weekly update (10 May). Due to changes in the structure of ECHA's updates, we can no longer link to updates themselves. To ensure BIVDA members continue to receive this information, we have opted to provide the full ECHA notification. ECHA Conference 2024 – save the date and share your ideas The next ECHA Conference…

adminMay 12, 2023

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

MHRA weekly update (WC 08 May)

Please note this is an extract of the original bulletin. Register medical devices to place on the market Page summary: How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland Change made: Changes to DORS instructions for Scenarios 1 to 4 in the Guidance on registration…

adminMay 12, 2023

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

DEFRA weekly update (WC 24 Apr)

Please note this is an extract of the original bulletin. Businesses approved to export to the EU Page summary: Use the lists to check if your business in Great Britain or one of the Crown Dependencies is approved to export to the EU and find out what your TRACES number is. Change made: Updated the lists of businesses approved to…

adminMay 12, 2023

OPSS weekly update (WC 01 May)

Please note this is an extract of the original bulletin. Designated standards: new or amended notices of publication Page summary: Proposed updates to the lists of standards for businesses. Change made: Proposals to amend added for equipment for explosive atmospheres and low voltage equipment. Time updated: 1:08pm, 2 May 2023 Simple Pressure Vessels (Safety) Regulations 2016 Page summary: Guidance…

adminMay 12, 2023

European Commission Updates Environmental Newsletter European Commission Updates Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

Safe and Sustainable by Design (SSbD) framework testing phase – deadline 30 June

The EU Framework for Safe and Sustainable by Design is aimed at those researching and manufacturing chemicals and materials. The first reporting period of the Safe and Sustainable by Design (SSbD) framework testing phase is open until 30 June 2023. If applicable, members are invited to fill in the reporting template, which can be found and submitted via this link.…

adminMay 12, 2023

Office for Life Sciences – publications (WC 08 May)

The Office for Life Sciences have published their latest updates. OLS bulletin - 9 May OLS borders bulletin - 5 May These include updates on news, including the Russia/Ukraine conflict, regulatory updates, transitional guidance and events

adminMay 12, 2023

European Commission Updates Regulatory Affairs Newsletter European Commission Updates Regulatory Affairs Newsletter Archive MedTech Europe Updates Regulatory Affairs Newsletter MedTech Europe Updates Regulatory Affairs Newsletter Archive Regulatory Affairs Newsletter Regulatory Affairs Newsletter Archive

EU Notified bodies urging to submit Class D legacy devices’ application sooner

As the transitional deadlines for IVD devices are fast approaching, the Notified Bodies have communicated with MedTech Europe to encourage manufacturers to submit their applications for compliance with the IVD Regulation as early as possible. Manufacturers are urged to submit applications for Class D legacy devices before end-2023, in order to meet the deadline of 26 May 2025.

adminMay 12, 2023

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

DHSC weekly update (WC 01 May)

Please note this is an extract of the original bulletin. EM on EU decision to amend EU Regulation 2017/745 (COM(2022)721) Page summary: The Governments summary of a proposal of the European Parliament and the Council on fees and charges payable to the European Medicines Agency. Change made: First published. Time updated: 9:48am, 3 May 2023

adminMay 12, 2023

APHA weekly update (WC 01 May)

Please note this is an extract of the original bulletin. Animal by-product operating plants: approved premises Page summary: Details of approved and registered animal by-product (ABP) operating plants in Great Britain and the Channel Islands. Change made: Updated the approved animal by-product plants in Great Britain list. Time updated: 2:06pm, 2 May 2023 Animal by-products for purposes outside the feed…

adminMay 12, 2023

BEIS weekly update (WC 01 May)

Please note this is an extract of the original bulletin. ESF Action Notes: 2014 to 2020 programme Page summary: Action notes to inform European Social Fund (ESF) grant recipients of an action they must complete. Change made: ESF Action Note Action required: Annual Review of 1720 Staff Hourly Rates that affect costs in the Q4 2023 claim has been…

adminMay 12, 2023