IVD Devices

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 apply 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?  In this… 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) in May 2020 is a cause of much concern for… 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

Authorised Representative EUDR New EU Medical Device Regulations_ The Impact for Economic Operators

Brexit & Notified Bodies – What Are The Implications for the Medical Devices Sector?

The implications of Brexit will, possibly, be felt most in the area of Notified Bodies.  The UK’s exit from the… Read more

What You Need To Know About the EU MDR & The Authorised Representative

Two new EU Regulations entered into force on 26th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU)… 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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