Medical Writing Medical Devices New rules for artificial intelligence in Europe
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Volume 31, Issue 2 - Medical Devices

New rules for artificial intelligence in Europe

Abstract

The proposal for a European Artificial Intelligence Act is unsettling medical device manufacturers because it might change the risk assessment of their devices and cause additional efforts regarding vigilance and technical documentation. Conflicting regulations complicate the situation further. The proposal is currently being discussed and will be applicable at the earliest in the second half of 2024, providing time for further adjustments and clarification

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Editorial
EMWA 30 years and 53 conferences later
Incoming President's Message
Outgoing President's Message
EMWA News
Foreword from the European Commission
Differences between writing for medical devices and pharmaceuticals: An update
Implantable medical devices: Preclinical testing in new product development – on the road to clinical reality
EU sourcing requirements for animal-derived materials
The clinical development plan
A beginner´s guide to writing clinical investigation plans and reports for medical devices
Clinical evaluation reports: 6 years after the introduction of MEDDEV 2.7/1 revision 4
Post-market clinical follow-up insights
The periodic safety update report and post market surveillance report under the new EU Medical Device Regulation
New rules for artificial intelligence in Europe
How the EU Medical Device Regulation is affecting the medical device landscape. An interview with Suzanne Halliday, the Regulatory Head of BSI, Medical Devices Notified Body
Optimizing the value of regulatory writers
Value of medical writing: The regulator's perspective
Value of medical writing: The regulatory writer's perspective
Winner of the Geoff Hall Scholarship Essay Competition
Biotechnology
Getting Your Foot in the Door
Good Writing Practice
In the Bookstores
Lingua Franca and Beyond
My First Medical Writing
News from the EMA
Pharmacovigilance
The Crofter: Sustainable Communications
Regulatory Matters
Regulatory Public Disclosure
Veterinary Medical Writing

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Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Barbara Grossman

Daniela Nakagawa

John Plant

Sampoorna Rappaz

Joselita T. Salita

Petal Smart

Amy Whereat

Section Editors

Jennifer Bell

Biotechnology

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk