European Medical Writers Association

MD SIG objectives

To provide a forum for EMWA members to discuss and share information in the area of medical devices and in vitro devices.
To ensure focus is given to this rapidly evolving medical communication speciality.
To support the implementation of the new EU Medical Device Regulation (MDR 2017/45) and the In Vitro Device Regulation (IVDR 2017/746).
To act as a resource and support group for medical communicators interested in getting into this field.
To increase the educational offerings of EMWA relevant to this field.

Organisation

Co-chairs: Namrata Upadhyay, Beate Walter
Committee members: Raquel Billiones, Katharina Friedrich, Kelly Goodwin Burri
MEW Medical Device Section Editor: Payal Bhatia
Supporting members: open to any interested EMWA member

Regular activities

The MD SIG meets on the first Friday of the month throughout the year to discuss ongoing projects and current topics of interest.

Our regular activities include:

Hosting discussions on topics of interest to medical device writers (“Meet & Share” sessions).
Planning and development of new EMWA workshops and other educational offerings (Expert Seminar Series and webinars).
Contributing to the Medical Device Section in the EMWA journal Medical Writing.
Providing networking opportunities virtually and at EMWA conferences.

Get involved

All EMWA members interested in writing for medical devices and networking with like-minded colleagues are welcome to join us. Please send an e-mail to MD-SIG@emwa.org to receive the latest MD SIG information and an invitation join our monthly calls.

Subgroups and topics

REGULATORY RESOURCES

Guidance documents from the Medical Device Coordination Group (MDCG)
Guidance documents International Medical Device Regulators Forum (IMDRF)
ISO14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice
European Database for Medical Devices (EUDAMED)
Database of Notified Bodies in the EU (NANDO)
Competent Authorities for Medical Devices in Europe (CAMD)

RESOURCES IN THE EMWA JOURNAL

Medical Devices Issue June 2017 Volume 26, Issue 2
Kelly Goodwin Burri, Adrian Spoerri (2020). The value of registry data in the clinical evaluation of medical devices Volume 29, Issue 2
Payal Bhatia, Laura C. Collada Ali, Kelly Goodwin Burri, Gillian Pritchard, Namrata Singh, Namrata Upadhyay (2020). New documents required by the medical device regulation Volume 29, Issue 3
Gauri Jawdekar-Abraham, Raquel Billiones (2020). The In Vitro Diagnostics Regulation and the role of medicals writers Volume 29, Issue 3
Kelly Goodwin Burri (2019) Intelligent use of artificial intelligence for systematic reviews of medical devices Volume 28, Issue 4
Medical Devices MEW June 2022
Medical Devices MEW September 2021
Medical Devices MEW June 2021
Medical Devices MEW March 2021
Medical Devices MEW December 2020
Medical Devices MEW September 2020
Medical Devices MEW June 2020
Medical Devices MEW December 2019
Medical Devices MEW September 2019
Medical Devices MEW June 2019
Medical Devices MEW March 2019
Medical Devices MEW September 2018
Medical Devices MEW June 2018
Medical Devices MEW March 2018

EMWA WORKSHOPS ON MEDICAL DEVICES

MDF1: Basics of Writing for Medical Devices under the MEDEV rev. 4 and new Medical Devices Regulations, by Claudia Frumento (Foundation)
MDF2: Going from Pharma to Medical Devices, by Gillian Pritchard and Raquel Billiones (Foundation)
MDF3: Writing Clinical Investigation Plans for Medical Devices, by Beatrix Doerr (Foundation)
MDF4: Post-market Clinical Follow-up for Medical Devices, by Katharina Friedrich (Foundation)
MDF5: Understanding Instructions for Use of Medical Devices and Providing Support in Their Drafting, by Laura Collada Ali and Katharina Friedrich (Foundation)
MDF6: Safety Reporting for Medical Devices Part 1, by Beatrix Doerr (Foundation)
MDF7: Writing a Clinical Evaluation Plan for Medical Devices, by Katharina Friedrich (Foundation)
MDF8: Post-market Clinical Follow-up for Medical Devices, by Kelly Goodwin Burri and Samuel Hoare (Foundation)
MDA1: Literature Reviews for Medical Devices by Gillian Pritchard (Advanced)
MDA2/a: How to Write a Clinical Evaluation Report, by Gillian Pritchard/Claudia Frumento (Advanced))

COLLABORATION WITH OTHER SIGS AND GROUPS

Starting May 2021, MD-SIG collaborates with CORE-Reference, a unified ‘go-to’ information source on transparency and public disclosure (T&D) that cuts across all interventions (medicines, vaccines, devices). MD-SIG will provide device-specific T&D news and information to the news summary section.