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Call for Participation & Papers – ACAIN 2025 – 5th International Advanced Course & Symposium on Artificial Intelligence & Neuroscience, September 21-24 2025, Riva del Sole Resort & SPA, Tuscany * Course Registration: May 23 * Paper Submission: May 23

ACAIN 2025 - a conference of potential interest to members. W:  https://acain2025.icas.events E:  acain@icas.cc Symposium Deadline: Paper Submission (Symposium): by May 23 (AoE) https://acain2025.icas.events/symposium-call-for-papers/ https://easychair.org/conferences/?conf=acain2025 Course Deadline: Regular Registration (Course): by May 23 (AoE) https://acain2025.icas.events/course-description/ https://acain2025.icas.events/registration/ https://2025.iaiss.cc/deadlines/ LECTURERS: Panos Pardalos, University of Florida, USA Jose Principe, University of Florida, USA Maneesh Sahani, University College London, UK Jonathon Shlens,  Google DeepMind,…
Ben Kemp
May 15, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

BSI IVDR Documentation Submission guide

BSI have added a section on AI/ML documentation to their guidance on technical documentation submission: https://www.linkedin.com/posts/bsi-medical-devices_bsi-medical-devices-ivdr-documentation-activity-7325889686483202048-X1A1?utm_source=share&utm_medium=member_android&rcm=ACoAAAAeH9EBFpe2TIKx6c7gKShKVeAb46UjtpM
Ben Kemp
May 15, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Register for #ModSim2025 before June 30 to SAVE!

 Industry's Premier Event for CM&S Innovation  Register Before June 30 & Save BIG! In an era where AI and computational modeling are reshaping medical device development, credibility is key. The 2025 Symposium on Computational Modeling and Simulation brings together industry leaders, regulators, and researchers to advance trusted, validated models that support safer, more effective medical technologies. Join us at #ModSim2025 to explore cutting-edge solutions, enhance regulatory confidence,…
Ben Kemp
May 9, 2025
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA announces more frequent inspections and unannounced audits of foreign manufacturing facilities

FDA announces more frequent inspections and unannounced audits of foreign manufacturing facilities. There is also discussion on charging higher fees for foreign inspections, to help promote the move to US domestic manufacture. https://www.fda.gov/news-events/press-announcements/fda-announces-expanded-use-unannounced-inspections-foreign-manufacturing-facilities  
Ben Kemp
May 9, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Register now: EU webinar on non-communicable diseases

Register now: EU webinar on non-communicable diseases Friday 16 May 2025, 10.00-13.00 Non-communicable diseases (NCDs) such as cardiovascular diseases, diabetes, chronic respiratory diseases, mental disorders, neurological disorders, or cancer are responsible for 80% of the disease burden in the EU Member States and the leading causes of avoidable premature deaths. The human and financial costs of NCDs are high and…
Ben Kemp
May 9, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU MIR form updated to version 7.3.1

Dear Members, please be advised that the MDCG have updated the Manufacturer Incident Reporting form (MIR form) to version 7.3.1 which will become mandatory from November 2025 (6 month transition). This includes updates for machine to machine data transfers. View article... Note 1 : the form is not compatible with EUDAMED, and can not be used to generate XML output…
Ben Kemp
May 9, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU IVDR Harmonization request updated

Dear Members, please be advised the MDCG have updated the EU IVD Regulation standards harmonisation request to include two updated European standards EN 556-1:2024 - Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medical devices EN556-2:2024 - Sterilization of medical devices - Requirements for medical devices to be…
Ben Kemp
May 9, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

(EU) 2024/1860 – IVDR 26 May 2025 deadline approaching

A reminder that manufacturers wanting to keep EU IVDD certified products on the market will need an EU IVD Regulation compliant QMS in place by 26th May 2025. And also a reminder to not delay submitting products for IVDR conformity assessment. (EU) 2024/1860 – IVDR 26 May 2025 deadline approaching Manufacturers are required to put in place an IVDR compliant…
Ben Kemp
May 9, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New MedTech Europe leaflet – Four urgent targeted measures – MDR/IVDR implementation

As part of MTE's advocacy efforts on the Future of Regulatory System they are pleased to share the new leaflet outlining four key urgent targeted measures. Our sector calls for these key targeted measures to support the implementation of the MDR & IVDR. They should kick-in urgently and ahead of the anticipated legal reform in 2026. The four targeted measures…
Ben Kemp
May 9, 2025
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