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News & Insights

Medical Literature Monitoring

Medical Literature Monitoring (MLM) – Current Status

The 1st September 2015 saw the rollout of the European Medicines Agency’s (EMA’s) much anticipated medical literature monitoring (MLM) service. […]

DMF Deadline

FDA Seeks Input on New Technology for Conducting Clinical Trials

Last October saw the publication of a request for comments from the FDA on new technologies and methods for conducting […]

Periodic Safety Update Single Assessment

Periodic Safety Update Single Assessment (PSUSA) – An Overview

In this blog we look at the Periodic Safety Update Single Assessment  or PSUSA.

GVP Pharmacovigilance and social media - Acorn Regulatory

2015: Good Pharmacovigilance Practice (GvP) and Social Media

Editor’s Note:  This article about GvP and social media is one of the most read articles ever on our website.  […]

In Vitro Diagnostic Medical Device Regulations Acorn Regulatory

The Steps to CE Marking a Medical Device

CE Marking a medical device and placing it on the market in the EU requires a number of steps need to […]

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 […]

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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. […]

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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 […]

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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 […]

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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 […]

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 […]

Acorn Regulatory Conducting Internal Audits

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 […]

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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