Medical Writing EU Regulations

Volume 29, Issue 3 - EU Regulations

September 2020

Download the full issue



President's Message

President's Message



Feature Articles

The In Vitro Diagnosgtics Regulation and the role of medicals writers

Eudamed's delay and its impact on discolsure of clinical investigations under the EU MDR

Recent and upcoming regulatory changes in the European Region: Opportunitiess for medical writers

New documents required by the medical device regulation

Risk management plans in the EU: Managing safety concerns

Scientific advice procedures in the EU – an overview ofthe regulatory background

EU software regulations: The new normal or innovation stagnation?

The new PubMed – underestimated regulatory obstacles

Ethical challenges in acknowledging professional writing support

Publication management software for medical writers

Regular Sections

Regulatory Matters

News from the EMA

Medical Devices

Medical Communications and Writing for Patients

Getting Your Foot in the Door

Lingua Franca and Beyond

My First Medical Writing

In the Bookstores

Good Writing Practice


Member Login


The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies


Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

Medical Writing is listed in the following indexes:

Editoral Board


Raquel Billiones


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


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


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