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Regulatory Affairs Newsletter

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Article 16(4) certification – relabelling and repackaging activities by importers and distributors

This following would apply to members based in Northern Ireland conducting these tasks, or members distributors, performing these tasks in the EU: Article 16(4) Certification Scheme As part of BSI’s commitment to ensuring patient safety while supporting timely market access to global medical device technologies, we are pleased to inform you that we are expanding our Notified Body services to…
Ben Kemp
October 1, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UKHSA Conference 2025

UKHSA Conference 2025 Page summary: Save the date for the UKHSA Conference 2025. Hosted at Manchester Central on 25 to 26 March in partnership with the Faculty of Public Health (FPH). Change made: Updated ‘submit an abstract’ as the submission period has now closed. Time updated: 12:30pm, 25 September 2024
Ben Kemp
October 1, 2024
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Guidance on Conducting Clinical Trials with Decentralized Elements

This guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials. Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants. Decentralized elements can include, among other things, telehealth visits with trial personnel, in-home visits with remote trial personnel, or visits with local health care providers. In…
Ben Kemp
September 25, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

European Artificial Intelligence Act

Medical device timelines and penalties The EU Artificial Intelligence Act (AIA) was approved on May 21, 2024. The AIA establishes requirements for compliance with AI systems and general-purpose AI (GPAI) models made available or used on the EU market. Stay ahead in the ever-evolving landscape of medical device regulations with our latest updates: AIA regulatory update 1 Scope, classification, conformity…
Ben Kemp
September 25, 2024
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Last Call: Register for AI in Health Care Virtual Event

Patients are rapidly adopting AI for everything from second opinions to self-diagnoses, appointment scheduling, and more. Health care organizations must act now to guide patients on using AI in order to minimize risk, boost their engagement and enhance the overall patient experience. Join us for our free virtual event on Octo‌ber 9th to hear experts in the field of AI…
Ben Kemp
September 25, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Cardiac Marker Dialogues 2024: Cardiac Biomarkers in Real Time

Don't miss the last chance to register for Cardiac Marker Dialogues 2024: Cardiac Biomarkers in Real Time - experiences and opportunities. There's not long until the meeting - book your place now! Hosted by UK NEQAS Cardiac Markers, Cardiac Marker Dialogues: Cardiac Biomarkers in Real Time - experiences and opportunities will be held in Glasgow on Thursday 26 - Friday…
Ben Kemp
September 25, 2024
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Importer Certification Statement Form Now Available

The CDC Import Permit Program (IPP) regulations provide that any noninfectious biological agent or biological substance that is being imported into the U.S. must be accompanied by an importer certification statement confirming that the material is not known to contain or suspected of containing an infectious biological agent or has been rendered noninfectious. See 42 CFR 71.54. To assist with…
Ben Kemp
September 25, 2024
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Boost Performance: CLSI EP47

CLSI EP47 provides guidance for planning, performing, evaluating, and documenting reagent carryover experiments and guidance for ensuring that no significant reagent carryover occurs. This document is intended for developers of in vitro diagnostic tests, regulatory organizations, and medical laboratories. Price: $180 for PDF; $200 for Print Access it here.
Ben Kemp
September 25, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Health Technology Assessment: Commission publishes new guidance on validity of clinical studies

The Commission has published a guidance document on the validity of clinical studies for joint clinical assessments under the EU Health Technology Assessment Regulation, adopted by the Member State Coordination Group. This guidance helps to define, classify, and assess the certainty of clinical study results in an objective, reproducible and transparent way. It covers the analysis of data from different types…
Ben Kemp
September 25, 2024
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