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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

EU RoHS – 2025

Please be advised that Oko Institute, have been appointed as the external consultant to review the June 2025 batch of EU RoHS exemption pack renewals or refusals. If any of these Annex III or Annex IV exemptions are applicable see the table for interested registrants. MedTech Europe usually coordinate responses for the European MD/IVD market. Note that there will need…
Ben Kemp
June 26, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU Standardization – consultation responses by 21st July 2025

EU consultation on the harmonization of standards process. EU want feedback by 21st July. Member responses need to constructive rather than a whinge. Standardisation Regulation – revision And Erik Vollebregt’s commentary https://www.linkedin.com/posts/erikvollebregt_standardization-medicaldevices-invitrodiagnostics-activity-7343026050060238848-JDqs?utm_source=share&utm_medium=member_ios&rcm=ACoAAAAeH9EBFpe2TIKx6c7gKShKVeAb46UjtpM I can send this out, but let me know if you want a BIVDA response (this directly impacts NI), and any specific text you’d like to included in…
Ben Kemp
June 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs Newsletter

Navigate Brazil UDI Requirements

Wednesday, June 25, 2025 | 9:00 AM – 9:45 AM (Austin Texas, U.S.) Join our Luiz levy and Lilian Pinheiro from Emergo by UL’s team, live (06/25/2025), from 9 – 9:45 a.m. CST as they share recent regulatory updates in Brazil. The presenters will provide more details on ANVISA’s regulatory agenda, as well as our perspective on the UDI requirements,…
Ben Kemp
June 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UK MHRA leads safe use of AI in healthcare as first country in new global network

UK MHRA leads safe use of AI in healthcare as first country in new global network Page summary: The MHRA will help shape international rules for AI in healthcare – speeding up access to safe, effective technologies into the NHS and worldwide. Change made: First published. Time updated: 2:20pm, 24 June 2025
Ben Kemp
June 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Register for the next IFCC Webinar: “The Role of Machine Learning in Advancing Pediatric Laboratory Medicine” – 30 June, 2025

The next IFCC webinar: "The Role of Machine Learning in Advancing Pediatric Laboratory Medicine" - will be held on June 30, 2025. Machine learning, is a powerful tool within artificial intelligence, which is revolutionizing diagnostics and predictive modeling across various medical fields. However, its application in neonatology and pediatrics, is still in its early stages. To accelerate its integration into…
Ben Kemp
June 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Update from GOV.UK for: UKHSA Presents

UKHSA Presents Page summary: 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. Change made: Updated next event details and added sign-up link. Time updated: 9:30am, 24 June 2025
Ben Kemp
June 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

HRA Now – updated model Commercial Chief Investigator Agreement and CRO version published

What: the model Commercial Chief Investigator Agreement (mCCIA) has been updated based on feedback, a contract research organisation (CRO) version has been published  Who: Commercial sponsors, contract research organisations (CROs), NHS and HSC organisations employing Chief Investigators  Where: UK wide (England, Northern Ireland, Scotland and Wales)  When: Friday 20 June 2025  An updated version of the model Commercial Chief Investigator Agreement (mCCIA) has been published for…
Ben Kemp
June 26, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Feedback needed on technical implementation issues with EU MIR 7.3.1

Please see below request for feedback regarding implementation issues with the EU MIR 7.3.1. I would need feedback by midday Monday 30th June please, to regulatory@bivda.org.uk Dear All, The European Commission has reached out to us with a request to provide feedback on the state of play of IT implementation of MIR 7.3.1 PDF file. The European Commission has received…
Ben Kemp
June 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Data (Use and Access) Act 2025

Regarding Data (Use and Access) Act 2025 which has been enacted. Covers England, Wales, Scotland and Northern Ireland, but to varying degrees across the four nations, see the enactment table towards the end of the document for details: An Act to make provision about access to customer data and business data; to make provision about services consisting of the use…
Ben Kemp
June 26, 2025
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