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New documents required by the medical device regulation - Volume 29, Issue

This article introduces four documents associated with the new Medical Device Regulation 2017/745: the clinical evaluation plan, post-market clinical follow-up (PMCF) plan and PMCF evaluation report, and the summary of safety and clinical…

Communicating the findings of health technology assessments: Considering uncertainty - Volume 30, Issue

Uncertainty is an unavoidable problem when analysing health technology assessment results, which can make decision making difficult. Whilst we have ways of presenting uncertainty for individual outcomes in a systematic review, we do not have a…

Translating medical devices: A rule-driven game - Volume 33, Issue

Translation for medical devices often presents a unique set of challenges arising from the products’ complex natures and associated regulatory requirements. Beyond medical expertise, linguists – from translators and editors to bilingual quality…

The Investigator's Brochure: A multidisciplinary document - Volume 23, Issue

The Investigator's Brochure (IB) is a multidisciplinary document that summarises the main elements of an entire development programme to date. Although the IB also serves other purposes, it is primarily written to enable investigators conducting…

Changes to working practices in medical communications during the COVID-19 pandemic: Insights from two surveys - Volume 31, Issue

Successive waves of COVID-19 have altered opinions and working practices. We conducted a survey in early 2020 among 759 members of the medical communications community, recruited via our network, seeking their experiences, opinions, and insights.…

Digital tools for the clinical evaluation of medical devices: A guide to empower regulatory writers - Volume 32, Issue

The implementation of the European Medical Device Regulation (EUMDR) has driven innovation in the digitalisation and the development of artificial intelligence (AI)-powered automations for regulatory writing. This article explores a selection of…

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…

Fake news and vaccination: How the Science Anti-Fake News team in Argentina is fighting the infodemic - Volume 31, Issue

At the outset of the pandemic, it became clear that misinformation (“fake news”) on COVID-19 was spreading rapidly. In this article, we discuss our efforts to combat misinformation by joining with researchers from various disciplines in Argentina to…

COVID-19 contagion, information, and misinformation - Volume 29, Issue

The set of reactions being observed in the current coronavirus outbreak is similar to that in other epidemics: the Severe Acute Respiratory Syndrome, the swine flu H1N1 pandemic, and the Middle East Respiratory Syndrome. Indeed, progress has been…

If a misinformed voice speaks out in the wilderness and no one refutes it, does it make a sound? A call to advocacy - Volume 22, Issue

The pharmaceutical industry has been a soft target for many years. Attacks by journalists, politicians, and the lay public tend to be triggered by publications with which professional medical writers are associated. Fault is found, either in the…

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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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