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Ben Kemp

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
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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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