PRRC: Person Responsible for Regulatory Compliance
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...
EUDAMED Registration: Download our slide deck
With the introduction of the new Medical Device Regulations (MDR) since 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...
How Unique Device Identifiers Work
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...
What is a Medical Device under MDR 2017/245?
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...
Understanding the Changes of MDR in 2021
The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others in the devices sector. The new regulations have brought about many changes compared to the previous regulatory framework. We look...
The Latest Acorn Regulatory Newsletter
May 2021 Covid-19 related travel restrictions have driven many audits online. While the audit might now be conducted online, it still needs to be prepared properly and it needs to run smoothly. We look at how you can prepare and...
How To Prepare for Remote Audits
Current restrictions on travel, brought about by Covid-19, have resulted in the increase in remote audits being carried out by health authorities. While there might not be an auditor sitting across a meeting room table from you, there are still...
Download Our Repeat Use Procedure Slide Deck
The issue of Repeat Use Procedures generates many questions to our pharmaceutical regulatory affairs team. We have created a slide deck looking at the main points to consider when completing a Repeat Sue Procedure. You can download it below.
Update on the new Veterinary Medicines Regulation (Regulation (EU) 2019/6)
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...
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Watch The Northern Ireland Protocol Webinar
Acorn Regulatory hosted a webinar in association with TOPRA on March 4th, 2021 to look at the issue of the Northern Ireland Protocol from a consultancy standpoint. The webinar was a fully booked event and generated significant interest among regulatory...
