The Government's amendment modifies the use of UKCA marking in the context of CE marking recognition. You can find it here.
Ben KempJuly 16, 2024
On 9 July 2024, WHO announced the launch of the first global open-access platform for medical devices: MeDevIS. MeDevIS references two international naming systems for medical devices - the European Medical Device Nomenclature (EMDN), mostly used in European countries for registration in the European database, and the Global Medical Device Nomenclature (GMDN) used in regulatory agencies in Australia, Canada, the…
Ben KempJuly 16, 2024
24 July 2024 This session, led by experts from H2 compliance, aims to clarify labeling for consumers and professionals in the US by: reviewing applicable regulations and OSHA interpretation letters on the consumer-professional labeling scenario; reviewing the differences and similarities between each set of labeling requirements; and presenting an example method for unifying the labeling elements onto one product label.…
Ben KempJuly 16, 2024
31 July - 9am This webinar offers clear guidance on: CSRD timelines and how it’s different from existing legislation The link between the CSRD and the European Sustainability Reporting Standards (ESRS) Identifying what needs to be reported — and what doesn’t Recognizing the urgency of starting your CSRD compliance program now Practical steps to kickstart your compliance journey Find out…
Ben KempJuly 16, 2024
Many UK customers use the European Patent Office’s (EPO) Online Filing (eOLF) software to file patents. In November last year, the EPO announced changes to the service to modernise access to their online services. As a result, customers who use it will need to take action to continue accessing eOLF. What action do I need to take?
Ben KempJuly 16, 2024
New laws and regulations at the state and federal levels in the U.S. are anticipated to create mandatory requirements for thousands of companies to provide climate-related reporting, in areas including value chain emissions and climate-related risks, even in the potential absence of climate reporting rules from the Securities and Exchange Commission (SEC), according to a new report by Fitch Group’s…
Ben KempJuly 16, 2024
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…
adminJuly 10, 2024
Please note this is an extract of the original bulletin. Businesses approved to export to the EU Page summary: 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 export to the EU.…
adminJuly 10, 2024
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…
adminJuly 10, 2024
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…
adminJuly 10, 2024