MDD Devices

EU MDR: What Will The Impact Be For Economic Operators?

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

Regulatory Affairs Consultant Vacancy

Join Our Team!

We are growing at a rapid pace at Acorn Regulatory.  Right now, we are seeking to hire a 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

Outsourcing Regulatory Affairs

Benefits of Outsourcing Regulatory Affairs

The developments in the market, mergers and the issues associated with pricing pressures applied by governments (such as the IPHA… Read more

CE Marking A Medical Device

CE Marking a Medical Device

CE marking a medical device and placing it on the market in the EU requires several steps that need to… Read more

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… Read more

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