European Medical Writers Association

Medical Devices Special Interest Group (MD SIG)

Chair:

Raquel Billiones

Committee Members:

Beatrix Doerr

Jane Edwards

Gillian Pritchard

Kelly Goodwin Burri (MEW Medical Device Section Editor)

SIG Supporting Members:

Diarmuid De Faoite

Claudia Frumento

Namrata Singh

Payal Bhatia

Laura Collada Ali

Sarah Choudhury

Cherry Malonzo Marty

Sonia Costa

Namrata Upadhyay

Gauri Jawdekar-Abraham

The objectives of the MD SIG are:

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.

Activities in 2019:

Following the 2018 Symposium in Barcelona, the Medical Devices SIG has received requests to continue building up EMWA’s offerings focused on medical devices. We are happy to have successfully completed the 1st Expert Seminar Series (ESS) on Medical Devices in Vienna on Friday, 10 May 2019, 9:00 to 12:15, covering the following topics:

Drug-device combination products: regulations and documentation, by Viky Verna (confinis)
Medical device approval in Europe, US and Japan: similarities and differences, by Myriam Stieler (Biotronik)
Clinical evaluation, PMS/PMCF - requirements for plans and reports requirements with impact on medical writing, by Susanne Gerbl-Rieger (TÜV Süd)
Panel discussion

Workshops given as part of the EPDP Medical Device track:

* Writing Clinical Evaluation Reports (New, Advanced) by Claudia Frumento

* Literature Reviews for Medical Devices (Advanced) by Gillian Pritchard

* Going from Pharma to Medical Devices: Transferrable Medical Writing Skills (Foundation) by Gillian Pritchard and Raquel Billiones

Activities in 2018:

The EMWA Symposium on May 3, 2018 was entitled "Medical Devices and Technologies – Emerging Opportunities for Medical Communicators."
Workshops on medical devices were offered at the EMWA 2018 Spring Conference:
- Basics of Writing for Medical Devices under the new medical device regulations, by Claudia Frumento
- Systematic Literature Reviews for Clinical Evaluation Reports (NEW), by Gillian Pritchard
Medical Devices has been added as an area of expertise covered by for-credit workshops under the EMWA EPDP; more workshops will be offered in future conferences.
Raquel presented a webinar on medical devices on 13 March 2018 at 14:00 CET: Medical Devices: Key Regulations and Guidelines that Medical Writers Should Know.
Claudia and Gillian are spearheading the development of a standard CER template.
A section dedicated to medical devices was launched in Medical Writing in 2018.
Topics pertaining to Medical Devices will be included in the Expert Seminar Series (ESS) starting 2019