Category: Medical Devices

In our first article surrounding EU Medical Device Vigilance Reporting, we discussed medical device vigilance reporting requirements for IVD and medical device manufacturers. This article will address some frequently asked questions questions about vigilance reporting that we receive from clients.

As part of our ongoing review at the changes introduced with MDR, in this article we focus on Conformity Assessment routes. We provide a revised examination of the changes under MDR and the assessment routes for different device classifications.

Regulation (EU) 2017/745 on medical devices (MDR) has established specific requirements which focus on how manufacturers should establish and maintain a post market surveillance and vigilance system. This article examines how this will be implemented and sustained.

This revised article concentrates on the role of the Person Responsible for Regulatory Compliance (PRRC). The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European Medical Devices legislation...

We first published this article in 2020. This revised article considers the definition of a medical device and explore the types of products that may fall in under the classification of a medical device post May 2021. MDR 2017/245 covers...

The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others in the devices sector.  The new regulations have brought about many changes compared to the previous regulatory framework.  We look...