Get The Acorn Regulatory Medical Device Regulations Whitepaper
The new medical device regulations (MDR) will come into force in May 2020. In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations. For many companies there is...
The Medical Device Regulations – MDR – What You Need To Know
The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. Our medical device team has been working with many companies to support them for the changeover...
Get The Acorn Regulatory Medical Device Regulations Whitepaper
The new medical device regulations (MDR) will come into force in May 2020. In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations. For many companies there is...
EU Parliament Adopts New Diagnostics and Medical Device Regulations
The European Parliament has endorsed the new InVitro Diagnostic Medical Devices (IVDR) and the new Regulation on Medical Devices (MDR) at a sitting today (April 5th, 2017). The long-awaited final vote is the last step in an almost 8-year...
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...
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...
What You Need To Know About Drug Device Combination Products
The European medical devices regulation (MDR) 2017/745/EC was published on 5th May 2017 and has updated significantly the requirements for medical devices placed on the European market. It has introduced new requirements for manufacturers to comply with to achieve CE...
Download Our Drug-Device Whitepaper
The new MDR has significantly updated the requirements for medical devices placed on the European market. It has introduced new requirements for manufacturers to comply with to achieve CE marking before placing their products on the European market. Some of...
