Medical Device Regulation: A necessary step towards more patient and user safety - Volume 26, Issue

Abstract The new Medical Device Regulation (MDR) has recently been approved, and after a transition period of 5 years, all medical devices will be approved and marketed according to these new regulations. This article compares the main changes of…

French breast implants, the Medical Device Regulation, and a theoretical case study - Volume 26, Issue

Abstract The 2010-2011 Poly Implant Prothèse scandal triggered a review of the Medical Device Directive. This resulted in a new Medical Device Regulation that was approved this year. It contains many changes, and many questions will arise when…

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…

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…

The periodic safety update report and post market surveillance report under the new EU Medical Device Regulation - Volume 31, Issue

The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance…

Foreword: Writing for Patients, Foreword from the EMA - Volume 29, Issue

In recent years, regulators across the globe have improved the way they communicate to patients and the general public about their activities and how medicines are regulated.

EU Regulations - Volume 29, Issue

Overview of the European General Data Protection Regulation (GDPR) impact on medical writing for clinical trials - Volume 32, Issue

The European General Data Protection Regulation 2016/ 679 (GDPR) aims to ensure the security and privacy of individuals in the European Union (EU). Companies located within and outside of the EU must comply with GDPR when processing personal data…

The changing face of (benefit-)risk management - Volume 24, Issue

Over the last 20 years the focus of post-approval management of medicines has changed from risk management to the assessment and management of benefit-risk. In the EU this has been reinforced by changes in the legislation underpinning…

Bad karma - Volume 22, Issue

Bad Pharma provides a hyper-critical account of the pharmaceutical industry's approach to conducting, publishing and using clinical research and development. However, its attack on the drug regulators is unfair and its examination of the medical…