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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…

Staying ahead of the game in the changing arena of ethical medical communications - Viewpoint of a freelance medical writer - Volume 25, Issue

Laws, regulations, pharmaceutical industry codes of practice, and other guidelines play an important role in ethical medical communications. When working on medical education prog - rammes and materials, a professional medical writer must not only…

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…

News from the EMA - Volume 30, Issue

First CAR-T cell medicine for mantle cell lymphoma October 16, 2020 – The EMA has recommended granting a conditional marketing authorisation in the EU for Tecartus (autologous anti-CD19-transduced CD3+ cells) for the treatment of adult patients…

Race and ethnicity in biomedical literature: A narrative review - Volume 31, Issue

Race and ethnicity are not clearly defined in biomedical literature and misaligned with genomics and epigenomic findings; the guidelines for consistent reporting in publications and regulations from health authorities are lacking. Minority…

Medical Devices - Volume 30, Issue

Editorial ISO 14155 is an asset for every professional working in the medical device industry. With the new update to this standard, we see improved harmonisation and a clearer guidance to medical device manufacturers who are amidst transition to…

Out on Our Own - Volume 25, Issue

In this edition of OOOO, we are pleased to bring to you four diverse and thought provoking articles, and some practical tips. We thank you for your contributions and once again invite you to submit any articles that you wish to share with your…

The evolving landscape of medical education in oncology - Volume 21, Issue

The field of oncology is continuously evolving. The way in which cancer is diagnosed, staged, and managed has changed so much in the last decade, and awareness of the need for a ‘personalized medicine’ approach to patient management is growing. In…

The clinical development plan - Volume 31, Issue

The Medical Device Regulation (MDR) mentions the term “Clinical Development Plan” (CDP) only twice, both of which are in than the MDR into what the CDP entails and to propose the best strategies for a manufacturer to plan their medical…

The MHRA perspective on the new pharmacovigilance legislation - Volume 21, Issue

Following an extensive period of drafting, consultation, negotiation, and re-drafting the new European Legislation came into effect in July this year. The new measures will be the biggest change to medicines legislation since the creation of the…

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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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