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...
Download ‘Regulatory Intelligence 9’ from Acorn Regulatory
‘Regulatory Intelligence 9’ from Acorn Regulatory has a wide range of articles covering issues such as Brexit, the new Medical Device Regulations, DCP Close Outs, and more. The articles in ‘Regulatory Intelligence 9’ have been written by members of our...
Acorn Regulatory To Sponsor Global Access Conference 2020
Acorn Regulatory has announced that it will be one of the Silver Sponsors for the 2020 Global Access Conference hosted by Irish Medtech. The conference will be held virtually on October 29th and 30th. The conference, the largest medical device...
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...
How To Write An Effective CER
The clock is ticking for medical device manufacturers distributing in the European Union (EU). The EU is transitioning from the Medical Device Directive (MDD) to the new Medical Device Regulation (MDR). The updated European Medical Device Regulation (MDR) introduced in...
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.
Definition of a Medical Device: Explainer
MDR 2017/245 covers devices that previously fell under two separate European directives, the Medical Devices Directive (MDD 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD 90/385/EEC). In this article, we look at the definition of a medical device and...
Download ‘Regulatory Intelligence 8’
Edition 8 of the Acorn Regulatory whitepaper series ‘Regulatory Intelligence’ is out now and can be downloaded from our site. This bumper edition looks at a wide range of sectors including: pharmacovigilance, CMC & pharmaceutical, and medical device. In Regulatory...
