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Regulatory Affairs Newsletter Archive

Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Simple Pressure Vessels (Safety) Regulations 2016

Simple Pressure Vessels (Safety) Regulations 2016 Page summary: Guidance for businesses. Change made: Guides revised following legislation to extend recognition of CE marking on products being placed on the Great Britain market which came into effect on 1 October 2024. Time updated: 3:28pm, 4 December 2024
Ben Kemp
December 12, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Pressure Equipment (Safety) Regulations 2016

Pressure Equipment (Safety) Regulations 2016 Page summary: Guidance for businesses. Change made: Guides revised following legislation to extend recognition of CE marking on products being placed on the Great Britain market which came into effect on 1 October 2024. Time updated: 3:29pm, 4 December 2024
Ben Kemp
December 12, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Supply of Machinery (Safety) Regulations 2008

Supply of Machinery (Safety) Regulations 2008 Page summary: Guidance for businesses. Change made: Guides revised following legislation to extend recognition of CE marking on products being placed on the Great Britain market which came into effect on 1 October 2024. Time updated: 3:30pm, 4 December 2024
Ben Kemp
December 12, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Commission launches new platform for cross-border medical discussions on rare diseases

Commission launches new platform for cross-border medical discussions on rare diseases The Commission has launched a new IT platform for cross-border medical discussions on rare diseases. The Clinical Patient Management System 2.0 (CPMS 2.0) will support the European Reference Networks (ERNs) in improving the diagnosis and treatment of rare or low prevalence complex diseases across Member States. CPMS 2.0, which…
Ben Kemp
December 12, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

European commissioner for health appointed

Newly appointed European Commissioner for Health and Animal Welfare, Olivér Várhelyi speaks out at the EPSCO (EU member council for Employment, Social Policy, Health and Consumer Affairs) regarding Implementation of the MDR/IVDR. Read more here.
Ben Kemp
December 12, 2024
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA trials five innovative AI technologies as part of AI Airlock pilot

Five innovative technologies have been selected by the Medicines and Healthcare products Regulatory Agency (MHRA) for the AI Airlock, a pilot scheme to better understand how to regulate artificial intelligence (AI) powered medical devices in a way that that enables getting these types of products to the NHS and patients who need them as quickly and safely as possible. These…
Ben Kemp
December 9, 2024
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

2025 BIVDA Regulatory Affairs Seminar agenda released

The agenda for BIVDA’s 2025 Regulatory Affairs Seminar in Birmingham on February 11 - 12 2025 has now been released. Expert figures in diagnostics regulation including David Lawson, Director of Medical Technology, Department of Health and Social Care; Robyn Meurant, Principal Consultant, ACT-IVD; and Megha Deviprasad Iyer, Director of Global Strategic Regulatory Affairs, Thermo Fisher, will lead sessions designed to…
Ben Kemp
December 9, 2024
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MedTech Europe quarterly webinar for Partner Trade Associations around the World (Mon, 16 Dec 2024 3-4 pm CET)

On Monday, 16 December 2024 at 15:00 – 16:00 pm CET (Brussels time), MedTech Europe will host its next quarterly webinar regarding the implementation status of the EU in vitro Diagnostic Medical Devices and Medical Devices Regulations (IVDR and MDR) for its partner medtech trade associations around the world. The webinar will be 60 minutes in duration including a 30-minute…
Ben Kemp
December 5, 2024
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