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EU Medical Device Vigilance Reporting: FAQ

EU Medical Device Vigilance Reporting: FAQ

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...
Post Market Surveillance under MDR

Post Market Surveillance under 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....
PRRC: Person Responsible for Regulatory Compliance

PRRC: Person Responsible for Regulatory Compliance

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...
What is a Medical Device under MDR 2017/245?

What is a Medical Device under MDR 2017/245?

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...
The Northern Ireland Protocol & Medical Devices: Explained

The Northern Ireland Protocol & Medical Devices: Explained

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...
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