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European Commission Updates Regulatory Affairs Newsletter

European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveMedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Update: culture media and antibodies subject to additional Border Inspection Post controls

Please see below update from Medtech Europe regarding the proposal to include new CN codes in the EU Animal By-products legislation. See also the EC response to the issues posed by MedTech Europe. Please note that these requirements will also impact shipments from GB to Northern Ireland, as well as shipments from third countries to Northern Ireland, and shipments from…
Ben Kemp
June 9, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Swissmedic have updated their guidance on vigilance reporting to reflect the EU introduction of MIR form ver 7.3.1

Swissmedic have updated their guidance on vigilance reporting to reflect the EU introduction of MIR form ver 7.3.1 - www.bivda.org.uk/Portals/0/documents/Regulatory-Affairs/Misc%20docs/MU680_20_815e_WL_Guide_MIR_Manufacturer_Incident_Report_for_CH.pdf?ver=raJA0C2t47BhEDn4xJaWDA%3d%3d
Ben Kemp
May 23, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EN IEC 60335-2-104 – Particular requirements for appliances to recover and/or recycle refrigerant from air conditioning and refrigeration equipment

CENCENELC have adopted two standards regarding appliances to recover refrigerant from air conditioning or refrigeration equipment. Although they are not consumer product standards they maybe applicable if you supply equipment that includes refrigerant.   EN IEC 60335-2-104:2025 - Household and similar electrical appliances - Safety - Part 2-104: Particular requirements for appliances to recover and/or recycle refrigerant from air conditioning…
Ben Kemp
May 22, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32024R1781R(02): Corrigendum to Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/182

Corrigendum to Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828: EUR-Lex - 32024R1781R(02) - EN - EUR-Lex
Ben Kemp
May 15, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU MIR form updated to version 7.3.1

Dear Members, please be advised that the MDCG have updated the Manufacturer Incident Reporting form (MIR form) to version 7.3.1 which will become mandatory from November 2025 (6 month transition). This includes updates for machine to machine data transfers. View article... Note 1 : the form is not compatible with EUDAMED, and can not be used to generate XML output…
Ben Kemp
May 9, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU IVDR Harmonization request updated

Dear Members, please be advised the MDCG have updated the EU IVD Regulation standards harmonisation request to include two updated European standards EN 556-1:2024 - Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medical devices EN556-2:2024 - Sterilization of medical devices - Requirements for medical devices to be…
Ben Kemp
May 9, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

(EU) 2024/1860 – IVDR 26 May 2025 deadline approaching

A reminder that manufacturers wanting to keep EU IVDD certified products on the market will need an EU IVD Regulation compliant QMS in place by 26th May 2025. And also a reminder to not delay submitting products for IVDR conformity assessment. (EU) 2024/1860 – IVDR 26 May 2025 deadline approaching Manufacturers are required to put in place an IVDR compliant…
Ben Kemp
May 9, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

NANDO – 17th EU IVD Notified Body Designated

Dear members, a 17th EU Notified Body has been designated for the EU In Vitro Diagnostic Regulation 2017/746 NB 2460 DNV Product Assurance AS Norway See EUROPA – European Commission – Growth – Regulatory policy - SMCS for more details and their scope of designation.
Ben Kemp
May 9, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EUDAMED Plalyground User Guide Updates 20250425

EUDAMED Playground User guide for the UDI Devices module is updated to 3.0.11 as below - Legacy Device Registration: EUDAMED user guide - UDI Device: EUDAMED user guide - Registration of Old/custom-made devices in the Vigilance module: EUDAMED user guide - Vigilance for EOs: EUDAMED user guide - Market Surveillance: EUDAMED user guide
Ben Kemp
May 1, 2025
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