MDR

medical devices regulatory affairs

Do You Want To Progress Your Medical Devices Career?

We are growing at a rapid pace at Acorn Regulatory.  Right now, we are seeking to hire a Senior Medical… Read more

Drug Device Combination Products Acorn Regulatory

Drug Device Combination Products: An Acorn Regulatory Overview

The European medical devices regulation (MDR) 2017/745/EC was published on 5th May 2017 and has updated significantly the requirements for… Read more

MDD to MDR white

Moving from MDD to MDR? Here Is What You Need To Know

MDR will come in to force in 2021.  It differs greatly from the MDD.  What will the major changes be… Read more

Clinical Evaluation Reports

How To Write An Effective CER

The clock is ticking for medical device manufacturers distributing in the European Union (EU). The EU is transitioning from the… Read more

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

Essential Guide To MDR from Acorn Regulatory

Acorn Regulatory’s Essential Guide to MDR

Acorn Regulatory has been at the forefront of the MDR issue. The Essential Guide to MDR looks at the issue from… Read more

Definition of a medical device

Definition of a Medical Device: Explainer

MDR 2017/245 covers devices that previously fell under two separate European directives, the Medical Devices Directive (MDD 93/42/EEC) and the… Read more

Regulatory Intelligence 8

Download ‘Regulatory Intelligence 8’

Edition 8 of the Acorn Regulatory whitepaper series ‘Regulatory Intelligence’ is out now and can be downloaded from our site. … Read more

MDR Delay

MDR Delay -Will It Be Postponed?

The Covid-19 crisis has impacted every facet of modern life.  The life sciences sector has been at the centre of… 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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