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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 Archive

MDCG guidance on the classification rules for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746

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…
admin
July 10, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

Regulation (EU) 2024/1860 published on Official Journal of the European Union

On 09 July, the Regulation (EU) 2024/1860 amending the EU MDR and EU IVDR has been published in the Official Journal of the European Union (OJEU). This amends the EU MDR and EU IVDR by: Further extending the transition period for certain IVDs as long as they meet certain conditions. These devices can benefit from the following transitional period: 31…
admin
July 10, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

Public consultation: conflict-of-interest rules under the EU Health Technology Assessment Regulation

The European Commission have launched an online public consultation on the draft implementing act on the management of conflicts of interest in Health Technology Assessments. The draft implementing act provides rules for managing conflicts of interest of actors such as the representatives in the Member State Coordination Group and its subgroups, assessors, patients, and clinical and other experts who participate…
admin
June 4, 2024