News & Insights

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… Read more

EDMA Publishes a Position Paper on New EU IVD Regulation

In 2012, the European Commission proposed draft text for a new EU IVD regulation to replace the IVD directive 98/79/EC…. Read more

Acorn Regulatory to Exhibit at Med in Ireland – Dublin, October 29th 2015

Med in Ireland – October 29th 2015, Dublin Convention Centre, Ireland Acorn Regulatory is delighted to attend the Med in… Read more

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… Read more

DCP Applications To Be Accepted Only in eCTD format from July 1st 2015

Looking back on how far we have progressed from the standard paper submission one thing is clear –  the age… Read more

Medical Device Post-Market Obligations – a European Perspective: Part 1 – Post-Market Surveillance

Under the European IVD and medical device directives, once a Manufacturer has CE marked their device and placed it on… Read more

Conducting Internal Audits – Guidance from our Quality Team

Our quality team has a well deserved reputation for excellence.  In this blog they share their thoughts on what you need… Read more

EU Medical Device Vigilance Reporting: Part 2 – Frequently Asked Questions

  In part 1 of this series we gave you a quick overview of the medical device vigilance reporting requirements for IVD… Read more

EU Medical Device Vigilance Reporting – Part 1 – ‘The Abridged Guide’

If you are a manufacturer of an IVD or a medical device, once your product is on the market, you… Read more

Do You Want To Find Out About CE Marking An App? Find Out More Here

There has been a veritable explosion in the number of mobile apps which act as aids to patients and clinicians… Read more

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… Read more

Borderline Medical Devices Covered in EU Manual Update

With the rapid development of new software tools and mobile apps in healthcare, questions arising over classification will become increasingly… Read more