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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...
EU Medical Device Vigilance Reporting

EU Medical Device Vigilance Reporting

by elena@investinu.ie | Sep 27, 2021 | Acorn Regulatory News

All medical device manufacturers are required to have an effective system for the review and evaluation of customer complaints. The European Commission guidance MEDDEV 2.12/1 revision 8, describes the steps involved in the notification and evaluation of Incidents and...
MDR: An Essential Guide for 2021

MDR: An Essential Guide for 2021

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...
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...
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