Steps to CE Marking an IVD Medical Device

Steps to CE Marking an IVD Medical Device

This blog looks at the steps to CE Marking an IVD Device.


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 (PSUSA) – An Overview

In this blog we look at the Periodic Safety Update Single Assessment  or PSUSA. The World Health Organisation defines pharmacovigilance as […]

GVP Pharmacovigilance and social media - Acorn Regulatory

2015: Good Pharmacovigilance Practice (GvP) and Social Media

Good Pharmacovigilance Practice (GVP) at its core aims to prevent harm from adverse reactions in humans from medicines and to […]

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 […]


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. […]


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 […]


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 […]


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 […]

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