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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

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
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Working Party Chair and Vice Chair changes

BIVDA would like to update members on a number of changes to working party chairs and vice chairs. Regulatory Affairs Working Party Alison Gilles, Leica BioSystems, steps up at the Regulatory Affairs Working Party as Vice Chair, meaning that we’re back to full complement. UKCA Subgroup Emma Barringer is moving from chairing the Environmental WP to chairing the UKCA Subgroup.…
Ben Kemp
May 19, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA PMS and Vigilance reporting – Updated UK requirements

Last week, MHRA updated the PMS and Vigilance guidance page. They intend to continue to accept reporting for NI using the EU MIR and will transition to using 7.3.1 as per the EU deadline, however for GB reporting there is a new GB Schema that will be introduced and will need to be used from the date of application of…
Ben Kemp
May 19, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

APHA – Guidance: Intensified Official Controls at the EU Border

Guidance on what happens when Intensified Official Controls are triggered at the EU Border The Department for Environment, Food & Rural Affairs (Defra) has published new guidance aimed at businesses exporting animal products from Great Britain to the European Union. This guidance sets out the procedures and requirements for exporters if their consignments trigger Intensified Official Controls (IOCs) or Imposed…
Ben Kemp
May 15, 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
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Take action now and prepare for the EU’s RED legislation

The EU Radio Equipment Directive impacts devices using radio equipment, including IVD instruments with Wi-Fi, Bluetooth, Cellular or Near Field Communication, including RFID. The EU directive applies both in the EU and to products placed in Northern Ireland. GB Radio Equipment Regulations based on the EU assimilated law as at 1st Jan 2021 (as amended in UK Law): Address EU…
Ben Kemp
May 15, 2025
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