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Regulatory Affairs Newsletter Archive

European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU have updated their regulation regarding mercury-containing products

Regulation (EU) 2024/1849 of the European Parliament and of the Council of 13 June 2024 amending Regulation (EU) 2017/852 on mercury as regards dental amalgam and other mercury-added products subject to export, import and manufacturing restrictions Text with EEA relevance. You can find the legislation here.
Ben Kemp
July 17, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Directive (EU) 2024/1799 of the European Parliament and of the Council of 13 June 2024 on common rules promoting the repair of goods and amending Regulation (EU) 2017/2394 and Directives (EU) 2019/771 and (EU) 2020/1828Text with EEA

The EU have published their ‘right to repair’ directive. This is regarding consumer devices (listed in Annex II), with MDs and IVDs being out of scope. However we could see the scope widen in the future.   Article 1 Subject matter, purpose and scope   This Directive lays down common rules strengthening the provisions related to the repair of goods,…
Ben Kemp
July 17, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act)Text with EEA relevance.

The EU has published the AI ACT. The legislation can be found here.
Ben Kemp
July 17, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Working Time (Amendment) Regulations (Northern Ireland) 2024

These regulations amend the Working Time Regulations (Northern Ireland) 2016 to include express provision about the rights of workers, in certain circumstances, to carry forward annual leave into subsequent leave years and the calculation of holiday pay in relation to those rights.
Ben Kemp
July 16, 2024
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

For information: RoHS Umbrella Project letter Packs 22-24

Dear Members, please see below the notification from MedTech Europe regarding EU RoHS (but also impacting UK RoHS, as these assessments were kicked off prior to BREXIT). The Umbrella Project coordinates and submits applications for RoHS exemption packs when there is a more general and not specific sectorial exemptions. The main issues are: need for clarification of whether new applications…
Ben Kemp
July 16, 2024
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WHO launched MeDevIS platform with EMDN & GMDN

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 Kemp
July 16, 2024
Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Webinars: CSRD Deadline Prep: Your Essential Summer School Session

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 Kemp
July 16, 2024
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