Download our Clinical Evaluation Report Slide Deck
The most significant change from the MDD to the MDR is the increased focus on clinical evaluation, access to data, and post-market surveillance. This places a greater burden upon manufacturers and their representatives, and it is something that we, at...
Download Our MDR Changes Slide Deck
The new medical device regulations will be introduced in May 2021. The MDR changes will see an increased set of responsibilities for manufacturers, economic operators, authorised representatives, and distributors. Our MDR regulatory affairs consultants are currently working with companies to...
Sign Up To Receive Our New MDR Newsletter
Acorn Regulatory will launch a dedicated MDR newsletter in January 2021. The time-limited MDR newsletter will be published between January and May 2021 as the medical device sector gets ready for the introduction of the new medical device regulations.
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...
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...
Moving from MDD to MDR? Here Is What You Need To Know
MDR will come in to force in 2021. It differs greatly from the MDD. What will the major changes be for medical devices manufacturers, importers, and distributors? We look at the major changes in the move from MDD to MDR...
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...
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