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Medical Devices - Volume 29, Issue

May 2020 was set to be a busy month for medical device writers in Europe. The EU Medical Device Regulation (MDR) was to take effect on May 26, and we were anticipating lively discussions on the final MDR preparations with our fellow writers at the…

Veterinary Medical Writing - Volume 29, Issue

All three articles in this Veterinary Medical Writing section were written when COVID-19 was not classified as a pandemic. Yet all three articles tie into the current narrative of regulation in veterinary medicine and the need for communication…

News and Notes from the World of Medical Writing - Volume 30, Issue

EMWA’s Special Interest Group on Medical Communication initiated a reply to an article that made unfounded derogatory remarks about medical writers (MWs). Without providing any evidence, in an article about the development of randomised clinical…

The reproducibility crisis in preclinical research – lessons to learn from clinical research - Volume 26, Issue

In recent years, the robustness and reproducibility of preclinical data have been a topic for discussion. Quality standards and good practices are often not well defined for different in vitro methods and in vivo models,and not harmonised amongst…

Clinical trial disclosure and transparency - Volume 27, Issue

The initial requirements of clinical trial disclosure were to register a clinical trial to make it publicly accessible to patients and thereby making the enrolment into a clinical trial easier. In the meantime, the disclosure ofclinical trials in…

EMWA News - Volume 27, Issue

One of the benefits of being an EMWA member is having access to the webinar programme. In 2018, we are providing a new webinar almost every month of the year either in live or recordedformats. Thanks to our wonderful speakers, this year we’ve had…

Eudamed's delay and its impact on discolsure of clinical investigations under the EU MDR - Volume 29, Issue

The new European Database on Medical Devices (Eudamed) is the platform to be used for the prospective registration of clinical investigations for medical devices under the Medical Device Regulations. However, Eudamed’s launch has been delayed till…

Document management systems for medical writing - Volume 28, Issue

Clinical trial data are rightfully protected by robust regulations; given these requirements and increasing demands from clients, a validated and compliant electronic document management system is now a necessity for established medical writing…

New rules for artificial intelligence in Europe - Volume 31, Issue

The proposal for a European Artificial Intelligence Act is unsettling medical device manufacturers because it might change the risk assessment of their devices and cause additional efforts regarding vigilance and technical documentation. Conflicting…

Medical Devices: An exciting industry at a crossroads - Volume 26, Issue

Welcome to this special edition of Medical Writing focusing on medical devices. When I volunteered to act as the guest editor for this issue, I did so knowing that we are at a crossroads in Europe. The Medical Device Directive is about to be…

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Scope

Medical Writing is a quarterly publication that aims to educate and inform medical writers in Europe and beyond. Each issue focuses on a specific theme, and all issues include feature articles and regular columns on topics relevant to the practice of medical writing. We welcome articles providing practical advice to medical writers; guidelines and reviews/summaries/updates of guidelines published elsewhere; original research; opinion pieces; interviews; and review articles.

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