Medical Writing EU Regulations The In Vitro Diagnosgtics Regulation and the role of medicals writers

Volume 29, Issue 3 - EU Regulations

The In Vitro Diagnosgtics Regulation and the role of medicals writers

Abstract

Even though in vitro diagnostic medical devices (IVDs) occupy only a very small market segment in the healthcare sector, they have a vital role to play. The importance of diagnostics was strongly underlined during the COVID-19 pandemic. In the EU, IVDs are regulated under the In Vitro Diagnostics Regulation 2017/746 (IVDR), with the planned date of application in May 2022. This article gives an overview of IVDs and the regulatory requirements under the IVDR in comparison to the more well-known Medical Device Regulation 2017/745. Considering the similarities in the regulatory landscape and the document requirements of the two regulations, medical writers well versed in mainstream medical devices have the skills and competencies to support IVDs under the IVDR.

Download the full article

Search

Articles

Editorial
President's Message
EMWA News
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
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

Links

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

Editoral Board

Editor-in-Chief:

Co-Editor:

Managing Editor

show all +

Associate Editors:

Section Editors:

Ad-hoc Editors:

  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

Editor Emeritus: