Ben Kemp – Page 178 – BIVDA Newsletter

MedTech Europe Updates Regulatory Affairs Newsletter MedTech Europe Updates Regulatory Affairs Newsletter Archive Regulatory Affairs Newsletter Regulatory Affairs Newsletter Archive

Follow-up: MedTech Europe quarterly webinar for Partner Trade Associations

Dear Members, please see below link to the MedTech Europe Quarterly update. There is a significant focus on the review of the IVDR/MDR implementation. Following the MedTech Europe Quarterly Webinar held on 16 December 2024, please find below the link to watch the 30 minutes presentation held by our speakers, as well as the slide deck used during the meeting…

Ben KempDecember 19, 2024

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

The AI and Copyright Consultation has launched today

Today, the Intellectual Property Office (IPO), the Department of Culture, Media, and Sport (DCMS) and the Department for Science, Innovation and Technology (DSIT) launched the Consultation on Copyright and Artificial Intelligence. We welcome your views. The consultation will be open for responses from 17 December 2024 to 25 February 2025. Please share the consultation widely – we need to hear…

Ben KempDecember 19, 2024

Environmental Newsletter Environmental Newsletter Archive Industry newsletters Environmental Newsletter Industry Newsletters Environmental Newsletter Archive

California to Give Companies an Extra Year Before Fully Enforcing New Climate Reporting Rules

California to Give Companies an Extra Year Before Fully Enforcing New Climate Reporting Rules The California Air Resources Board (CARB), the regulator charged with developing and enforcing new regulations requiring large companies to disclose their value chain emissions and report on climate-related financial risks, announced that it will ease emissions reporting requirements and not pursue enforcement action in the first…

Ben KempDecember 19, 2024

Environmental Newsletter Environmental Newsletter Archive Industry newsletters Environmental Newsletter Industry Newsletters Environmental Newsletter Archive

Hong Kong to Require IFRS-Aligned Sustainability Reporting Starting in 2025

Hong Kong to Require IFRS-Aligned Sustainability Reporting Starting in 2025 The Hong Kong government announced the release of its Roadmap on Sustainability Disclosure in Hong Kong, outlining the details of its plans to implement sustainability reporting requirements for companies, with a view to introducing reporting based on the IFRS Foundation’s ISSB standards for some listed companies on a comply-or explain…

Ben KempDecember 19, 2024

Environmental Newsletter Environmental Newsletter Archive Industry newsletters Environmental Newsletter Industry Newsletters Environmental Newsletter Archive

Switzerland to Require Companies to Disclose 2050-Aligned Net Zero Roadmaps

If companies are not directly impacted, they could be indirectly impacted if they are suppliers to Swiss companies who are in scope, and are required to gather information from their supply chain to achieve their own reporting and environmental targets: Switzerland to Require Companies to Disclose 2050-Aligned Net Zero Roadmaps The Swiss government announced the launch of a consultation on…

Ben KempDecember 18, 2024

Environmental Newsletter Environmental Newsletter Archive UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive

The Climate Change (2040 Emissions Target) Regulations (Northern Ireland) 2024

Updated Net Zero targets for Northern Ireland - this will drive wider policy decisions in NI: The Climate Change (2040 Emissions Target) Regulations (Northern Ireland) 2024 The Climate Change (Carbon Budgets 2023-2037) Regulations (Northern Ireland) 2024

Ben KempDecember 18, 2024

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

COMBINE programme for clinical trials and medical devices endorsed by Member States

COMBINE programme for clinical trials and medical devices endorsed by Member States National authorities in Member States have endorsed a new strategy for the COMBINE programme, a cross-sector initiative to streamline combined studies of medicines and medical devices, including diagnostics. The COMBINE programme will be rolled out over the coming years through seven cross-sector projects. It aims to foster collaboration…

Ben KempDecember 18, 2024

Industry Newsletters Regulatory Affairs Newsletter Industry Newsletters Regulatory Affairs Newsletter Archive Regulatory Affairs Newsletter Regulatory Affairs Newsletter Archive

ISO / TS 16766:2024

You can find ISO/TS 16766:2024Manufacturers’ considerations for in vitro diagnostic medical devices in a public health emergency here.

Ben KempDecember 18, 2024

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

PPWR: Council adopts final Regulation

MTE update on the EU Packaging and Packaging Waste Regulation. MTE has worked hard for specific derogations (contact sensitive packaging) and extended timelines to address the issue of packaging traceability, and the need for the recycling market (specifically plastics (chemical) recycling ) to mature and meet sector requirements. To: STC, Circular Economy WG and TF PPWR Dear members, Please be…

Ben KempDecember 18, 2024

Industry Newsletters Regulatory Affairs Newsletter Industry Newsletters Regulatory Affairs Newsletter Archive Regulatory Affairs Newsletter Regulatory Affairs Newsletter Archive

Health Canada – Guide for recalling medical devices (GUI-0054)

Health Canada have issued updated guidance for medical device recalls - Overview: Guide for recalling medical devices (GUI-0054) - Canada.ca

Ben KempDecember 18, 2024