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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...
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...
How Will The Northern Ireland Protocol Impact Medical Device Companies?

How Will The Northern Ireland Protocol Impact Medical Device Companies?

by elena@investinu.ie | Dec 1, 2020 | Acorn Regulatory News, Brexit, Medical Devices

Our clients have been contacting us in recent weeks with questions relating to the Northern Ireland Protocol and medical devices.  They are eager to understand the intricacies of the Northern Ireland Protocol and how it will impact their companies.  We have gathered...
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