by elena@investinu.ie | Oct 27, 2021 | Acorn Regulatory News, Pharmacovigilance
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 about vigilance reporting that we...
by elena@investinu.ie | Sep 20, 2021 | Acorn Regulatory News, Medical Devices
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....
by elena@investinu.ie | Sep 8, 2021 | Acorn Regulatory News, Medical Devices
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 that a person is...
by elena@investinu.ie | Sep 6, 2021 | Acorn Regulatory News, Medical Devices
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 devices that were previously...
by elena@investinu.ie | Dec 6, 2020 | Acorn Regulatory News, Brexit, Medical Devices
How will the Northern Ireland Protocol impact companies in the medical devices sector? That is a question that we have been asked many times in recent months. Now, as the UK’s departure from the EU gets closer, we have created a brief guide on the Northern Ireland...
