Please ensure Javascript is enabled for purposes of website accessibility

Welcome to Regulatory Rapporteur. This site uses cookies. Read our policy.

  • Skip to main content
  • Skip to navigation
Site name
topra-logo

The Organisation for Professionals in Regulatory Affairs
Site name
Mast navigation
  • Become a member
  • Sign in
Search our site
Menu
Close menu
  • Regulatory Rapporteur - October 2024
  • Pharmaceuticals
    • Back to parent navigation item
    • Pharmaceuticals
    • Artificial intelligence
    • ATMP
    • Biologics
    • Chemistry, manufacturing and controls
    • Clinical trials
    • Non-clinical development
    • Oncology
    • Product information
    • Regulatory procedures
  • Veterinary
  • Medical devices
    • Back to parent navigation item
    • Medical devices
    • Combination products
    • In-vitro diagnostics
    • Software
    • Artificial intelligence
  • Industry news
    • Back to parent navigation item
    • Industry news
    • Industry news
      • Back to parent navigation item
      • Industry news
      • Read latest news
      • Video
  • Commentary
    • Back to parent navigation item
    • Commentary
    • Editorials
    • Letters to the Editor
    • Podcasts
  • Collections
    • Back to parent navigation item
    • Collections
    • Interviews
    • Symposium 2024
      • Back to parent navigation item
      • Symposium 2024
      • Annual lecture
    • Symposium 2023
      • Back to parent navigation item
      • Symposium 2023
      • Annual lecture
    • Symposium 2022
      • Back to parent navigation item
      • Symposium 2022
      • Annual lecture
    • Symposium 2021
      • Back to parent navigation item
      • Symposium 2021
      • Annual lecture
    • CPD supplements
      • Back to parent navigation item
      • CPD supplements
      • 2021/2022
      • 2020
      • 2019
  • JOIN TOPRA
  • topra-logo

    The Organisation for Professionals in Regulatory Affairs
  • Regulatory Rapporteur - October 2024
  • Pharmaceuticals
      • Artificial intelligence
      • ATMP
      • Biologics
      • Chemistry, manufacturing and controls
      • Clinical trials
      • Non-clinical development
      • Oncology
      • Product information
      • Regulatory procedures
    • RR-Nov-2024-Half-Cover
      November 2024 – Contents: Human medicines sessions
    • DADI_compressed
      Revolutionising compliance with DADI: a new frontier for digital integration
    • RR-Oct-2024-Half-Cover
      October 2024 – Contents
  • Veterinary
    • RR-Nov-2024-Half-Cover
      November 2024 – Contents: Veterinary medicines sessions
    • SUSIMPERATIVE_compressed
      The sustainability imperative for the healthcare sector
    • AdobeStock_537705324
      New data protection for maximum residue limits
    • AdobeStock_294025271
      EMA platform to monitor use of antimicrobials
  • Medical devices
      • Combination products
      • In-vitro diagnostics
      • Software
      • Artificial intelligence
    • RR-Nov-2024-Half-Cover
      November 2024 – Contents: Medical devices/IVDs sessions
    • elabels image_compressed
      E-labelling: revolutionising the labelling landscape
    • AdobeStock_841428142_compressed
      New approach methodologies for the biological safety assessment of medical devices
  • Industry news
      • Industry news
        • Read latest news
        • Video
    • WHO pandemic
      WHO Pandemic Agreement gains signatories
    • EMA AI
      Regulators publish new guidelines for use of AI
    • image
      New Editor-in-Chief for Regulatory Rapporteur
  • Commentary
      • Editorials
      • Letters to the Editor
      • Podcasts
    • Michael Kipping
      Improving health outcomes through regulatory excellence
    • AdobeStock_971129498_SMALL
      Chemistry, manufacturing and controls: accelerating development and boosting innovation
    • AdobeStock_922131460_small
      The complexities of botanical regulation
  • Collections
      • Interviews
      • Symposium 2024
        • Annual lecture
      • Symposium 2023
        • Annual lecture
      • Symposium 2022
        • Annual lecture
      • Symposium 2021
        • Annual lecture
      • CPD supplements
        • 2021/2022
        • 2020
        • 2019
    • Banner_new
      Streamline medical device compliance with BSI Compliance NavigatorSponsored by The UK's National Standards Body
    • AdobeStock_59790119
      The Olaratumab experience
    • AdobeStock_207448226
      Qualification of stride velocity endpoint in Duchenne Muscular Dystrophy
  • JOIN TOPRA
  • More from navigation items
Medical devices

November 2024 – Contents: Medical devices/IVDs sessions

  • No comments

 

RR-Nov-2024-Half-Cover

Regulatory
Rapporteur

 

Write to the Editor at publications@topra.org

November 2024  |  Vol. 21  |  No. 10

 

EDITORIAL

Improving health outcomes through regulatory excellence

Cover option 1 MichaelKipping

READ HERE

By Kornelia Grein, Sobhey Nassar and Marie Uguen

 

MEDICAL DEVICES/IVDs

MD1/IVD1/HM5: COMBINE project: A new era of combined clinical trials in Europe

MD1 -MargarethJorvid

READ HERE

By Erica Cypas

 

MEDICAL DEVICES/IVDS

MD2/IVD2: Unravelling AI as a medical device - Insights into the EU AI Act and other global perspectives

MD2 - AlexZaretsky

READ HERE

By Margareth Jorvid

 

MEDICAL DEVICES/IVDS

MD3: The impact of MDR/IVDR and its effect on future developments of policies, manufacturers and inspectorates

MD3 - CoenBrummer

READ HERE

By Maïté Barthel

 

MEDICAL DEVICES/IVDS

MD4/IVD4: UK MDR - Current requirements and future perspectives for medical devices and in vitro diagnostics

MD4 - AshleighBatchen

READ HERE

By Mehryar Behizad

 

MEDICAL DEVICES/IVDS

MD5/IVD5: Responsible and experienced PRRCs for MDR and IVDR

MD5 - NatashaBankowski

READ HERE

By Rachel Drapela

 

ANNUAL LECTURE

The TOPRA annual lecture: Status of global health 

AnnualLecture - IlonaKickbusch

READ HERE

By Margareth Jorvid

 

Topics

  • 2024
  • IVD
  • Medical Devices
  • November 2024
  • Symposium 2024
  • No comments

More from Medical devices

  • MD3 - CoenBrummer

    Journal

    MD3/IVD3: The impact of MDR/IVDR and its effect on future developments of policies, manufacturers and inspectorates

    2024-11-08T06:56:00Z By Maïté Barthel

  • MD1 -MargarethJorvid

    Journal

    HM5/MD1/IVD1: COMBINE project: A new era of combined clinical trials in Europe

    2024-11-08T06:52:00Z By Erica Cypas, Charlotte Holleran and Margareth Jorvid

  • AdobeStock_320295284

    Journal

    The UK Responsible Person Association

    2024-06-11T15:30:00Z By Mika Reinikainen and is chair of the UK Responsible Person Association

  • Med-Devices

    Journal

    Medical device standards update: March 2024

    2024-05-08T10:30:00Z By Mehryar Behizad and Charlotte Holleran

  • AdobeStock_357286256

    Journal

    The European Association of Authorised Representatives

    2024-05-08T10:30:00Z By Ludger Moeller

  • AdobeStock_172846643 (1)

    Journal

    Device submissions for combination products: a data-driven perspective

    2024-04-03T12:00:00Z By Ola Oyinloye

  • AdobeStock_669696959

    Journal

    Chemical characterisation: a critical first step for medical device development

    2024-02-08T00:05:00Z By Jocivania Oliveira da Silva and Marielle Fournier

  • AdobeStock_475728203

    Journal

    Overview of medical device regulations in Canada

    2024-02-08T00:05:00Z By Hasnaa Fatehi

Related articles

  • VM5 - IvoClaassen

    Journal

    VM5: Exploring the future of veterinary regulatory affairs – Harnessing science and innovation for animal health excellence

    2024-11-08T06:58:00Z By Jana Schalansky

  • VM4 - TomPaternoster-Howe

    Journal

    VM4: Advancing veterinary pharmacovigilance – Insights into signal management, first experiences with PhV inspections and introducing the EMA-ADR Data Quality Framework

    2024-11-08T06:58:00Z By Kornelia Grein

  • VM3 - RhonaMcHugh

    Journal

    VM3: Navigating the regulatory landscape of veterinary product information

    2024-11-08T06:57:00Z By Catarina Ferreira

  • VM1 - RickClayton

    Journal

    VM1: Advancing regulatory policies for One Health – A holistic approach to animal and public health

    2024-11-08T06:57:00Z By Kornelia Grein

  • VM2 - StéphanieGalleau

    Journal

    VM2: Progress in veterinary regulatory procedures – Opportunities and threats concerning the implementation of Regulation (EU) 2019/6

    2024-11-08T06:57:00Z By Rick Clayton

  • MD5 - NatashaBankowski

    Journal

    MD5/IVD5: Responsible and experienced PRRCs for MDR and IVDR

    2024-11-08T06:57:00Z By Rachel Drapela

  • MD4 - AshleighBatchen

    Journal

    MD4/IVD4: UK MDR – Current requirements and future perspectives for medical devices and in vitro diagnostics

    2024-11-08T06:56:00Z By Mehryar Behizad

  • PS2 - JuanGarciaBurgos

    Journal

    PS2: Patient experience data – The next steps towards medicines evaluation

    2024-11-08T06:56:00Z By Anna Koptina

No comments yet

You're not signed in.

Only registered users can comment on this article.

Sign in Register
  • What is Regulatory Affairs?
  • TOPRA Membership
  • Regulatory Rapporteur Editorial Board
  • Regulatory Rapporteur Editorial Area
  • Future Focus Topics
  • FAQs
  • Glossary
  • Privacy Policy
  • ISSN 2755-5070 (online)

    ISSN 1742-8955 (print - legacy)

Regulatory Rapporteur

The peer-reviewed journal, published 11 times per year and available free to TOPRA members.

Follow TOPRA
topra-logo

The Organisation for Professionals in Regulatory Affairs

TOPRA office
TOPRA Publishing, 6th Floor, 3 Harbour Exchange, South Quay, London E14 9GE, UK
Tel: +44 (0) 20 7510 2560
Email: publications@topra.org

TOPRA AISBL
Blvd du Souverain 280, 1160 Brussels, Belgium
Tel: +32 (0) 2 808 72 70

  • Contact us
  • Copyright © 2015-2024 The Organisation for Professionals in Regulatory Affairs Ltd. t/a Regulatory Rapporteur - All rights reserved

Site powered by Webvision Cloud