IVD Devices

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

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

10 Responsibilities of an EUAR

10 Responsibilities of a EU Authorised Representative

The responsibilities and role of the EU Authorised Representative (or EUAR) is now in the spotlight as a result of… Read more

Regulation on Medical Devices

EU Parliament Adopts New Diagnostics and Medical Device Regulations

  The European Parliament has endorsed the new InVitro Diagnostic Medical Devices (IVDR) and the new Regulation on Medical Devices… Read more

Most Read Medical Device News Stories on AcornRegulatory.com in 2016

We’re looking at the 5 most read medical device news stories from AcornRegulatory.com for the past 12 months.  What a… Read more

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

CE Marking a Medical Device That Incorporates a Medicine

We are consistently asked about CE marking a medical device.  Our team of medical device experts has written a brief… 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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