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Clinical evaluation reports: 6 years after the introduction of MEDDEV 2.7/1 revision 4 - Volume 31, Issue

MEDDEV 2.7/1 is the European guideline about the clinical evaluation of medical devices. The 4th revision, in 2016, updated how clinical evaluation should be conducted and reported, thus paving the way for clinical evaluation under the Medical…

Plain language summaries of clinical trial results: What is their role, and should patients and AI be involved? - Volume 33, Issue

Plain language summaries (PLSs) of clinical trial results are vital tools in the clinical development process for enhancing transparency and encouraging and facilitating patient engagement. The production of a PLS is now mandated in the EU for all…

Writing in plain language for the Summary of Safety and Clinical Performance: Communicating medical device safety and performance data to patients - Volume 34, Issue

Effective communication with patients is paramount in the medical field, particularly in the medical device sector, where the complexity of information can create barriers to understanding. The Summary of Safety and Clinical Performance (SSCP) has…

Profile - Volume 26, Issue

The new European medical device regulation and guidance document on clinical evaluation An Interview with Dr Bassil Akra The successor of the currently applicable Medical Device Directives (MDD 93/42/EEC and 90/385/EE) combines both directives…

Measuring health outcomes: The foundation of contemporary healthcare decision-making - Volume 27, Issue

Healthcare professionals and patients are (or should be) interested in understanding the benefits of health care. We should be able to know the expected treatment benefits and to see quantifiable evidence that supports those expectations. Such…

Message from the President - Volume 22, Issue

Dear Medical Writers It is time for me to give you another brief update on the activities of the EMWA Executive Committee (EC) and our plans for 2013, as well as a short preview on the spring conference in Manchester. The autumn conference…

Value of medical writing: The regulatory writer's perspective - Volume 31, Issue

The American Medical Writers Association formed a working group in 2020 focused on understanding and communicating the value that regulatory medical writers contribute to project teams, companies, and the wider research community. The working…

The 2023 CORE Reference Utility Survey: Perceptions on a best practice tool for globally applicable clinical study reporting and provision of continuing professional development resources for the regulatory medical writing community - Volume 33, Issue

CORE Reference offers globally applicable resources for clinical study reporting, including a user manual and a mapping tool, and continuous professional development (CPD) resources. This report presents the results of the 2023 Utility Survey conduct…

Improving patient communication by writing with empathy - Volume 21, Issue

Medical writers’ texts are either written for specialists or for non-professionals such as patients and their relatives. Medical writers whose work is intended for patients cannot merely impart facts. They also need to demonstrate that they…

Outgoing President's Message - Volume 31, Issue

Dear friends, colleagues, and EMWA members, despite the global COVID-19 pandemic and the war in the Ukraine, EMWA’s financial situation and membership numbers remained stable over my term of presidency. In fact, membership numbers slightly…

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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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