IVD Devices

CE Marking A Medical Device

CE Marking a Medical Device

CE marking a medical device and placing it on the market in the EU requires several steps that need to… Read more

In Vitro Diagnostic Medical Device Regulations Acorn Regulatory

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

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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

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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

EU Medical Device Vigilance Reporting - Part 1 - 'The Abridged Guide' - Acorn Regulatory

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

EU Medical Device Vigilance Reporting - Part 1 - 'The Abridged Guide' - Acorn Regulatory

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' - Acorn Regulatory

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

CE Marking An App

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

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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… Read more

Contact us and enjoy a faster, smoother journey through the maze of European Pharmaceutical and Medical Device legislation with us as your expert guide.
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