Introducing EMWA’s new AI Working Group - Volume 32, Issue

Artificial Intelligence (AI) is a broad umbrella term that refers to the use of computer algorithms to perform tasks that typically require human-like intelligence, such as reasoning, learning, decision-making, and perception. The new EMWA AI…

Foreword from the European Commission - Volume 31, Issue

Already 1 year has passed since the date of application of the new Medical Devices Regulation (EU) 2017/745 (MDR), replacing the previous Directives 90/385/EEC and 93/42/EEC from 26 May 2021, while for the new In Vitro Diagnostic Medical Devices…

Regulatory Public Disclosure - Volume 31, Issue

A great deal has happened in the world of regulatory public disclosure in Europe in 2022 with the EU Clinical Trials Regulation (CTR) 536/2014 coming into force at the end of January 2022. We collectively attempt to assimilate knowledge and…

The Lay Protocol Synopsis: Requirements and feasibility - Volume 32, Issue

The EU Regulation 536/2014 included a requirement for companies to produce a Protocol Synopsis with a recommendation for a version in lay language. This requirement stated, among other things, a maximum length of two pages. This article outlines the…

Nanoapplications – From geckos to human health - Volume 23, Issue

Nanotechnology, the manipulation of matter on a molecular scale, is all around us in our everyday lives. Chocolate, non-dairy creamer, and sunscreen are examples of consumer products with a high content of nanoparticles. Nanotechnology holds great…

Medical Devices - Volume 29, Issue

After the cancellation of EMWA’s Spring Conference this year, EMWA’s Medical Device Special Interest Group stepped up to ensure that members did not miss out on the Expert Seminar Series (ESS) by organising a virtual version of the event.

The Webscout - Volume 21, Issue

Cannabinoids in oncology: more than a palliative Usually you have chemotherapeutics and biologicals in mind when you are talking about oncology. Would you have thought of cannabinoids? I don't think so but for decades, cannabinoids have been known…

The Light Stuff - Volume 23, Issue

I love deadlines, I like the sound they make as they fly by Douglas Adams, English writer, humorist & dramatist (1952–2001).Illustration: Gemma Hobbs, Downham Market, UK. Answers to Medical Writing Jumble #10:PRINT, TRAIN, SAFETY,…

Post-approval regulatory writing - Volume 23, Issue

Medical Devices - Volume 32, Issue

Spotlight on similar devices under the Medical Device Regulation This article evaluates the potential of similar devices in clinical documentations, such as clinical evaluation plans (CEPs), clinical evaluation reports (CERs), and post-market…