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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...
EUDAMED Registration: Download our slide deck

EUDAMED Registration: Download our slide deck

by elena@investinu.ie | Sep 6, 2021 | Acorn Regulatory News, Medical Devices

With the introduction of the new Medical Device Regulations (MDR) in May 2021, we have noticed many new processes and systems being introduced. One of these has been the registration of all Medical Device Manufacturers in a totally new system called EUDAMED. We have...
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...
How Unique Device Identifiers Work

How Unique Device Identifiers Work

by elena@investinu.ie | Sep 6, 2021 | Acorn Regulatory News, Medical Devices

The Unique Device Identifiers system under the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on all participants of the supply chain. The overall objective of which is to improve patient safety by means of better...
Update on the new Veterinary Medicines Regulation (Regulation (EU) 2019/6)

Update on the new Veterinary Medicines Regulation (Regulation (EU) 2019/6)

by elena@investinu.ie | Mar 23, 2021 | Acorn Regulatory News, Veterinary

The new veterinary medicines regulation (Regulation (EU) 2019/6) will come into force in January 2022.  It will modernise the existing rules on the authorisation and use of veterinary medicines in the European Union. The new regulation seeks to simplify the regulatory...
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