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Regulatory Affairs Newsletter Archive

Brexit Update (WC 10 Feb) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Update (WC 10 Feb)

Apply to import multiple low value parcels on one declaration Page summary: You can use the bulk import reduced data set to declare one or more low value parcels in a single import declaration when you import goods into Great Britain. Change made: Updated the eligibility information in the sections ‘who can use the bulk import reduced data set’ and…
Ben Kemp
February 17, 2025
LIVE Webinar: Decoding the EU AI Act Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

LIVE Webinar: Decoding the EU AI Act

Tue, Mar 4, 2025 3:00 PM - 4:00 PM GMT The EU AI Act has significant implications for medical devices and in vitro diagnostics (IVD) incorporating artificial intelligence. Join our webinar to discover the latest insights on how to integrate the requirements of the Act in an efficient manner. The webinar consists of a 45-minute presentation and a live Q&A.…
Ben Kemp
February 17, 2025
EMA Q&A on combinations MD/IVD/medicinal products European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EMA Q&A on combinations MD/IVD/medicinal products

An update from EMA on guidance especially for companion diagnostics. Note that this EU guidance also impacts Northern Ireland as it continues to follow the EU IVD Regulation. The document can be found here.  
Ben Kemp
February 17, 2025
CI/PS coordinated assessment pilot officially launched European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CI/PS coordinated assessment pilot officially launched

Please note that the European Commission has launched a dedicated website for clinical investigations and performance studies coordinated assessment pilot: Medical Devices - Clinical investigations and performance studies - European Commission and with this also officially opened the call for expression of interest for the Clinical Investigations (MD) pilot: Pilot coordinated assessment for CI/PS - European Commission For medical devices:…
Ben Kemp
February 14, 2025
Coordinated assessment for clinical investigations: a call for expression of interest European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Coordinated assessment for clinical investigations: a call for expression of interest

The EU have opened their  Coordinated assessment for clinical investigations: a call for expression of interest webpage.
Ben Kemp
February 14, 2025
BIVDA announce partnership with MedBoard BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

BIVDA announce partnership with MedBoard

  BIVDA is excited to announce a new partnership with MedBoard, an innovative cloud platform that centralises global medical, MedTech, Digital Health, and Pharma information. MedBoard empowers professionals, teams, and organisations with accessible, cutting-edge digital tools to enhance their work and decision-making. As part of this collaboration, BIVDA members can enjoy exclusive discounts on their first-year MedBoard subscription – a…
Ben Kemp
February 12, 2025
17th International Congress in Paediatric Laboratory Medicine (ICPLM)- EuroMedLab Brussels 2025 Satellite Meeting 18th May 2005 Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

17th International Congress in Paediatric Laboratory Medicine (ICPLM)- EuroMedLab Brussels 2025 Satellite Meeting 18th May 2005

The International Congress of Paediatric Laboratory Medicine (ICPLM) is to be held on Sunday May 18, 2025, in Brussels, as a Satellite to the main XXVI IFCC-EFLM EuroMedLab 2025. This special conference is being organized by the IFCC Committee on Emerging Technologies in Paedia­tric Laboratory Medicine (C-ETPLM) with the support of the IFCC Congresses and Conferen­ces Committee as well as…
Ben Kemp
February 7, 2025
Health Technology Assessment: The Commission opens first request submission period for joint scientific consultations European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Health Technology Assessment: The Commission opens first request submission period for joint scientific consultations

The European Commission has launched the first request submission period for joint scientific consultations (JSCs) under the Health Technology Assessment Regulation (EU) 2021/2282. The JSCs enable health technology developers (HTDs) to exchange information with regulatory authorities on their development plans for a medicinal product or medical device. They also enable HTDs to obtain guidance on the information, data, analyses, and…
Ben Kemp
February 7, 2025
DSIT Update (WC 3 Feb) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Update (WC 3 Feb)

International AI Safety Report 2025 Page summary: A report on the state of advanced AI capabilities and risks – written by 100 AI experts including representatives nominated by 33 countries and intergovernmental organisations. Change made: First published. Time updated: 1:16pm, 29 January 2025 First International AI Safety Report to inform discussions at AI Action Summit Page summary: First Independent International…
Ben Kemp
February 7, 2025