Medical Writing Medical Devices EU sourcing requirements for animal-derived materials
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Volume 31, Issue 2 - Medical Devices

EU sourcing requirements for animal-derived materials

Abstract

Regenerative medical products derived from animal tissue have been used to successfully treat millions of patients. As they are manufactured from animal sources, there are bio-contamination and biocompatibility risks that must be addressed in accordance with ISO 22442 for receipt of the CE Mark and subsequent EU commercialisation. This article discusses important regulatory animal sourcing requirements associated with medical devices that cover these biological risks. These requirements include risk management, animal health controls, quality system elements, and demonstration of safety related to potential transmissible pathogens. The necessary information needs to be presented in the form of reports, risk analyses, and other documentation.

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Articles

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 Brooks Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir

AI/Automation

Jennifer Bell

Biotechnology

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Adriana Rocha

Freelancing

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Pablo Izquierdo / Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer

Publications

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Jeff Blair / Luiza Ventura

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk