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Regulatory Affairs Newsletter Archive

NANDO update – 2 new Notified Bodies for IVDR added European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

NANDO update – 2 new Notified Bodies for IVDR added

Dear Members, not one, but two new notified bodies designated under the EU IVD Regulation 2017/746 and added to NANDO: SGS Belgium NV and IMQ Instituto Italiano Del Marchio Di Qulaita S.P.A Italy This makes it 16 Notified Bodies so far, out of the 22 applications. As always, if interested in using these new notified bodies you need to check…
Ben Kemp
April 30, 2025
IBMS London Branch World Sickle Cell Day Seminar – Wednesday 19th June! Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

IBMS London Branch World Sickle Cell Day Seminar – Wednesday 19th June!

IBMS London Branch World Sickle Cell Day Seminar - Wednesday 19th June! Wednesday, 19th June, is World Sickle Cell Day, and the IBMS London Branch has organised a seminar with the speakers Calvin Campbell and Hazel Attua, sickle cell individuals who will share their lived experiences. Sarah Babalola, the Project Manager of Give Blood, Spread Love, will talk about the…
Ben Kemp
April 30, 2025
Get discounted MedBoard services with your BIVDA membership BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Get discounted MedBoard services with your BIVDA membership

Thanks to our partnership with MedBoard, members can receive discounts on the first year of their MedBoard subscription. MedBoard is an innovative cloud platform that centralises global medical, MedTech, Digital Health, and Pharma information. empowering professionals, teams, and organisations with accessible, cutting-edge digital tools to enhance their work and decision-making. By using the code BIVDAMEDBOARD, the following discounts will apply:…
Ben Kemp
April 29, 2025
8 May | UK Post Market Surveillance Regulations Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

8 May | UK Post Market Surveillance Regulations

Details: 🗓️ Date: 8 May 2025 ⏰ 4:00 - 5:00 PM CET | 3:00 - 4:00 PM GMT đź”— Register Now and Save Your Spot!   The latest UK Post-Market Surveillance Regulations will have significant implications for your business. Join our webinar to explore the purpose of the new regulations, the key changes, and the differences and impact on CE-marked…
Ben Kemp
April 23, 2025
MedTech regulatory reform and the importance of partnerships Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MedTech regulatory reform and the importance of partnerships

A new post, “MedTech regulatory reform and the importance of partnerships” has just been published on the MedRegs blog. Medical technologies will play a critical role in delivering the government’s 10 Year Health Plan and its three shifts: hospital to community; analogue to digital; and sickness to prevention. Risk-proportionate regulation, which ensures patient safety whilst supporting innovation and access. Read…
Ben Kemp
April 23, 2025
Defra – Border Target Operating Model – getting it right at the border 10 04 25 Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Defra – Border Target Operating Model – getting it right at the border 10 04 25

Border Trade Newsletter – getting it right at the border  This newsletter from the Animal and Plant Health Agency (APHA) covers the latest operational updates on requirements and border controls for importing live animals, germinal products, products of animal origin and animal by-products into Great Britain. In this newsletter: FMD Austria update – Changes to fresh meat of ungulates listing…
Ben Kemp
April 23, 2025
Register now for Clinical Evaluation of Software as a Medical Device – 14 May 2025 Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Register now for Clinical Evaluation of Software as a Medical Device – 14 May 2025

Join us for our Clinical Evaluation for Software as a Medical Device webinar on 14 May 2025 This webinar will provide an overview of MDR requirements as applied to Software as a Medical device (SaMD). It will also aim to highlight common issues seen in the Clinical Evaluation of SaMDs. What will participants gain? Participants will gain an insight as…
Ben Kemp
April 23, 2025
UKHSA Presents: New AI event added Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UKHSA Presents: New AI event added

UKHSA Presents is a new webinar series profiling the science behind how we prevent, prepare for and respond to infectious diseases and environmental hazards to keep all our communities safe. A new AI event has been added, which can be viewed here.
Ben Kemp
April 23, 2025