CE Marking a Medical Device That Incorporates a Medicine
We are consistently asked about CE marking a medical device. Our team of medical device experts has written a brief overview of how a company can secure CE marking for a medical device that incorporates a medicine.
The Implications of Brexit on the Pharmaceutical, Medical Devices & Clinical Trials Sectors
Acorn Regulatory has published a whitepaper looking at the potential implications of Brexit on a number of healthcare sectors. The document looks at the impact of the UK’s decision to leave the EU on institutions such as the EMA. It also...
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Update on the new EU In Vitro Diagnostic Medical Device Regulation: Seven Key Changes
Editor’s note: This post was first published in November 2015. Since then we have written extensively on the issue of medical devices and the MDR/IVDR. You can read more about devices here. You will see that some of our comprehensive...
Medical Device Post-Market Obligations, a European Perspective: Part 2 – Assessing Product Changes
Last week, in the first part of this series, we outlined the post-market obligations for Manufacturers under the European IVD and medical device directives. In the second part of this series we are going to discuss another post-market topic – change...
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New European Medical Device and IVD Regulation – Where is it?
The long anticipated wait for agreement and adoption of the new European Medical Device and IVD Regulations will go on a little longer. Current predictions are that the new legislation will be adopted no sooner than Q4 2015, possibly extending...
EUDAMED Registration: Download our slide deck
With the introduction of the new Medical Device Regulations (MDR) since 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...
The Latest Acorn Regulatory Newsletter
May 2021 Covid-19 related travel restrictions have driven many audits online. While the audit might now be conducted online, it still needs to be prepared properly and it needs to run smoothly. We look at how you can prepare and...
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.
