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Regulatory Affairs Newsletter Archive

Upcoming RCC Volunteer Opportunities Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Upcoming RCC Volunteer Opportunities

RAPS are looking for volunteers to join their Regulatory Compliance Certification Program (RCC) IVD Steering Committee. If you are interested, please fill out and submit the form below: https://connect.raps.org/volunteeropportunities/opportunities-list-public/volunteer-opportunity-details?VolunteerOpportunityKey=29c88aa3-0173-4c28-8e39-0190b796f74e&returnurl=https%3A%2F%2Fconnect.raps.org%2Fvolunteeropportunities%2Fopportunities-list-public   Please click here for more information and to sign up: Regulatory Compliance Certification (RCC) Item Bank Maintenance Join the RCC-MDR Committee Join the RCC-IVDR Committee
Ben Kemp
September 4, 2024
Register now for Rollout of EU Reference Laboratories for IVDR Class D devices – 26 September 2024 Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Register now for Rollout of EU Reference Laboratories for IVDR Class D devices – 26 September 2024

Join us for our Rollout of EURLs webinar on 26 September 2024 Hear our subject matter experts Alex Laan, Head of Notified Body – IVD, Sara Fabi, Regulatory Lead – IVD as they discuss the newly enrolled EURL regulation. Class D devices manufacturers will gain more insights in the newly enrolled EURL regulation and will be better prepared for the…
Ben Kemp
September 4, 2024
The Misuse of Drugs Act 1971 (Amendment) Order 2024 Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Misuse of Drugs Act 1971 (Amendment) Order 2024

Draft legislation has been raised for the The Misuse of Drugs Act 1971 (Amendment) Order 2024 (legislation.gov.uk) This maybe of interest to members who provide Drugs of Abuse testing assays, calibrators and controls.
Ben Kemp
September 4, 2024
EFLM – Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for quality improvement Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EFLM – Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for quality improvement

The EFLM Task Force "Direct-to-Consumer Testing" has published the following scientific paper: Direct-to-consumer testing as consumer initiated testing: compromises to the testing process and opportunities for quality improvement. You can access it here.
Ben Kemp
September 4, 2024
DSIT Update Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Update

Philippines: UK Science & Innovation Network Summary Page summary: A summary from UK Science and Innovation Network (SIN) on science and innovation in the Philippines including UK SIN priorities and successes. Change made: First published. Time updated: 10:01am, 28 August 2024 Responsible AI Toolkit Page summary: Toolkit for practitioners to support the responsible use of AI systems. Change made: Added…
Ben Kemp
September 4, 2024
DBT Update (WC 2 Sept) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Update (WC 2 Sept)

DBT national survey of registered businesses’ exporting behaviours, attitudes and needs Page summary: Insights on UK companies’ views of exporting, including perceptions around trade barriers. Change made: DBT national survey of registered businesses’ exporting behaviours, attitudes and needs 2023 added to collection page. Time updated: 9:30am, 29 August 2024 DBT national survey of registered businesses’ exporting behaviours, attitudes and needs…
Ben Kemp
September 4, 2024
MHRA Updates (WC 2 Sept) Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 2 Sept)

Notify MHRA about a clinical investigation for a medical device Page summary: Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Updated to include new QSR template Time updated: 11:09am, 27 August 2024   MHRA consultation on statutory fees – proposals on ongoing cost recovery Page summary: Consultation…
Ben Kemp
September 4, 2024