IVD Devices

MDR Delay: Regulations Delayed Until May 2021

The MDR delay has been anticipated for some time, as a result of the Covid-19 pandemic.  The European Parliament has… Read more

The Risk Based Classification System Under IVDR 2017/746

One of the key changes in the new IVDR Regulation 2017/746, is the introduction of a risk-based classification system for… Read more

Unique Device Identifiers MDR Acorn Regulatory

How Unique Device Identifiers Will Work Under MDR

The Unique Device Identifiers system under the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on… Read more

Steps to CE Marking an IVD Medical Device

Steps to CE Marking an IVD Medical Device

One of the most frequent questions we are asked is: how do you CE mark an IVD device?  We will… Read more

Most Read Medical Device Articles of 2019

2019 has been a busy year for people involved in the medical devices sector.  The imminent arrival of MDR, on… Read more

LRQA medical device

Impacted By The LRQA Decision? Here Is How We Can Help

The decisions by Lloyd’s Register Quality Assurance (the LRQA) and QS Zurich that they will both will cease to offer… Read more

Understanding MDR: 8 Important Changes

The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others… Read more

EU Authorized Representative – Find Out What You Need To Know As Brexit Nears

In recent months we have assisted a large number of companies in transferring their EU Authorized Representative from the UK… Read more

2018’s Most Read Medical Device Articles from Acorn Regulatory

The Acorn Regulatory medical devices team has grown again in 2018 and in the past 12 months we have worked… 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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