News & Insights

Acorn Regulatory’s Essential Publications

In recent years, we have produced over 25 well-regarded publications. We have looked at topics as diverse as Brexit, CMC,… Read more

Acorn Regulatory’s Essential Guide to Pharmacovigilance

The Acorn Regulatory Pharmacovigilance team works with a range of clients around the world.  Our essential guide looks at the… Read more

Acorn Regulatory’s Essential Guide to Clinical & Medical Affairs

Our Medical & Clinical Services team works with companies all around the world and assists them with issues such as… Read more

Acorn Regulatory’s Essential Guide to Brexit

Acorn Regulatory has led the way in providing information and assistance to industry professionals since 2016.  We have compiled some… 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.  While many economic operators across the industry have been… Read more

Essential Guide To How To & Explainers

Acorn Regulatory’s Essential Guide to How-To’s & Explainers

Acorn Regulatory’s website has a wealth of articles that assist regulatory, pharmacovigilance and clinical professionals all over the world.  We… 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 Update – Will MDR Be Delayed?

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

WDA Updated for 2020

Wholesale Distribution Authorisation: Updated Guide for 2020

There has been significant growth in the number of companies seeking a pharmaceutical Wholesale Distribution Authorisation in Ireland (WDA) in… Read more

Clinical Evaluation Report Requirements Under MDR

Regulation (EU) 2017/745 has expanded the requirements related to Clinical Evaluation and Clinical Investigations with Chapter VI (Articles 61 to 82) covering this… 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

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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