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Recording, reporting and evaluating side effects during clinical trials on drugs and after the drugs’ marketing authorisation is imperative for the safety of patients. With medical devices, too, patient safety has priority. Unlike with drugs, though, the safety of users and third parties is also recorded here. This article shall highlight the differences between an…

At the moment, everyone is talking about the GDPR (Spanish abbreviation RGPD). It has led to many changes, especially for clinical trials, where special emphasis is placed on data protection. Especially patient information sheets and informed consent forms must be revised thoroughly. On 9 July 2018 the responsible Spanish authority Agencia Española de Medicamentos y Productos Sanitarios…

Strategies for the timely creation of a clinical evaluation report (CER)   With the introduction of the MDR (EU Regulation 2017/745), manufacturers of medical devices are faced with enormous challenges. Additional capacities are necessary to completely revise the documentation of all products. Not only the usability file, classification and large parts of the technical documentation including…

An ethics committee assesses the ethical aspects of applications for the conduct of clinical trials of medicinal products and medical devices. First and foremost, this is meant to safeguard the rights and the safety of the patients. For this reason, an ethics committee reviews not only the study protocol, but also the investigators’ qualification, along…

– what the abbreviations mean and what reporting obligations and deadlines exist – During a clinical trial, it is crucial to record, report and assess side effects to ensure the patients’ safety. The difference between an adverse event (AE) and a serious adverse event (SAE), and the concept of SUSARs (suspected unexpected serious adverse reactions)…