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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…

Medical decision making at the individual and population level: The increasing role of evidence - Volume 30, Issue

The major change in medical decision making over the last 50 years has been the realisation that treatment decisions would be improved if doctors’ existing knowledge was supplemented by evidence generated systematically through health services…

Anonymisation: A new challenge for medical writers - Volume 27, Issue

In its commitment to transparency, the EMA implemented Policy/0043 and Policy/0070 to make data accessible to all; however, this has given rise to the need for anonymisation of personal data in clinical reports. The analysis of the 64 submission…

Implantable medical devices: Preclinical testing in new product development – on the road to clinical reality - Volume 31, Issue

Implantable medical devices (IMDs) have restored viable and meaningful lives to millions of people who would have otherwise continued to be severely restricted or suffered early death due to their pathologies. Research and development of IMDs are…

Medical Communications - Volume 26, Issue

Dear all,The legal side of our job is something that most of us usually give little thought to. We assume that as scientists, we are automatically on the “right side” and therefore pretty bulletproof. Why should the law affect us, as longas we have…

What medical writers need to know about regulatory approval of mobile health and digital healthcare devices - Volume 28, Issue

The rapid growth of mobile health (mHealth) led to the development of internationally harmonised guidance for software as a medical device (SaMD) by the International Medical Device Regulators Forum (IMDRF), covering definitions, risk…

Recent and upcoming regulatory changes in the European Region: Opportunitiess for medical writers - Volume 29, Issue

The European regulatory landscape for clinical trials and medical devices is in the midst of major transformation. Older policies are giving way to new regulations that emphasise more harmonised and streamlined processes for document submittal,…

Transition to the EU Clinical Trials Regulation: Trick or treat? - Volume 32, Issue

The etiquette in clinical trial research requires companies to respect rules and to be precise and accurate. The new EU Clinical Trials Regulation 536/2014 (EU CTR) pushes companies and health authorities one step further – to be more flexible and…

Catching the wave of lifestyle medicine - Volume 28, Issue

Non-communicable diseases (degenerative chronic diseases) are wreaking havoc on human health, causing 70% of deaths world - wide, but lifestyle medicine is ready to tackle them by helping people change the habits behind them. A new medical…

Instructions for Authors

Instructions for Authors SCOPE Medical Writing, the official journal of EMWA (the European Medical Writers Association), is a quarterly journal that aims to educate, inform, and entertain medical writers. Medical Writing publishes themed issues…

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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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