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 | Oct 12, 2021 | Acorn Regulatory News, Medical Devices
MDR 2017/745, which was enforced on May 26th, 2021, expands the responsibilities of importers and distributors. This article will examine the revised responsibilities of the importer and the distributor under the new regulation. What is an Importer under MDR 2017/745?...
by elena@investinu.ie | Sep 24, 2021 | Acorn Regulatory News, Medical Devices
We published our first essential guide to MDR in 2020. Since then, the new MDR regulation has been introduced. This updated essential guide for 2021 provides a fresh outlook on the challenges surrounding MDR. Acorn Regulatory has been at the forefront of the MDR...
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...
