Medical Writing Medical Devices New EU medical device regulations: Impact on the MedTech sector

Volume 26, Issue 2 - Medical Devices

New EU medical device regulations: Impact on the MedTech sector

Abstract

Abstract

Regulation plays a fundamental role in the translation of innovative medical devices from concept to clinical application and ensures that only devices that exhibit the highest standards of safety and quality are released onto the EU Single Market for sale and clinical use. The impending introduction of a revised Medical Device Regulatory Frame - work in the EU will require an assessment of how stakeholders in the MedTech sector will be affected. Understanding the impact will be essential for maintaining compliance in the changing regulatory environment as well as for promoting commercial competitiveness and facilitating early access to innovative medical device technologies. In Ireland, a national initiative has been launched to centralise expertise on the regulatory require - ments for medical devices in the EU and to analyse how the new medical device regulations will affect requirements for medical device clinical investigations and commercialisation of medical device technologies.
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References

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Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

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Victoria White

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Alicia Waltman

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Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Joselita T. Salita

Amy Whereat

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Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Raquel Billiones

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

Jennifer Clemens

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Karim Montasser

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk