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...
The Northern Ireland Protocol & Medical Devices: Explained
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...
How Will The Northern Ireland Protocol Impact Medical Device Companies?
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...
What Is A Unique Device Identifier?
The Unique Device Identifier system under the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on all participants of the supply chain with the final aim to improve patient safety through better traceability and transparency. Both...
MDR Delay: Regulations Delayed Until May 2021
The MDR delay has been anticipated for some time, as a result of the Covid-19 pandemic. The European Parliament has now voted to formalise the delay and to suspend introduction of MDR until May 2021.
The Risk Based Classification System Under IVDR 2017/746
One of the key changes in the new IVDR Regulation 2017/746, is the introduction of a risk-based classification system for IVD devices. Under the new risk-based classification system, the majority of IVD devices will need to undergo a Notified Body...
How Unique Device Identifiers Will Work Under MDR
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 with the final aim to improve patient safety through better traceability and transparency. Both...
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Steps to CE Marking an IVD Medical Device
One of the most frequent questions we are asked is: how do you CE mark an IVD device? We will look at the steps that you need to take to obtain when CE marking an IVD device. As the new...
Most Read Medical Device Articles of 2019
2019 has been a busy year for people involved in the medical devices sector. The imminent arrival of MDR, on May 26th next year, is concentrating the minds of those within the industry. It has been a busy year also...
Impacted By The LRQA Decision? Here Is How We Can Help
The decisions by Lloyd’s Register Quality Assurance (the LRQA) and QS Zurich that they will both will cease to offer notified body services under the EU’s existing medical device and in vitro diagnostic directives and that they will not seek...
