News & Insights

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

monthly Brexit regulatory newsletter

Brexit Regulatory Issues: What You Need To Know

Brexit has been an ever-present issue for professionals in the life sciences sector since 2016.  We have worked with many… Read more

WDA in Ireland

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

Regulatory Intelligence 7

Download ‘Regulatory Intelligence 7’ from Acorn Regulatory

‘Regulatory Intelligence 7’ is now available to download.  It is the latest edition in our popular series ‘Regulatory Intelligence’. 

Understanding MDR The Role of the PRRC Responsible Person

PRRC: The 5 Responsibilities of the Person Responsible for Regulatory Compliance under MDR

This article is part of our series of MDR articles that look at the changes coming into play with the… Read more

Insights In Your Inbox: Subscribe to the Acorn Regulatory Newsletter

Subscribe to the Acorn Regulatory Newsletter

The Acorn Regulatory Newsletter is read by life science professionals around the world every month.  We cover the stories that impact… Read more

Clinical Investigation MDR

Carrying Out A Clinical Investigation Under MDR

As part of our ongoing MDR series, we are looking at clinical investigations and how they will operate after the… Read more

PSUSA Deadline How To Guide

How To Prepare For A PSUSA Deadline

Do you have a PSUR Single Assessment (PSUSA) submission deadline approaching?  If so, our Regulatory Publishing Manager, Eileen Ryan, has… Read more

Medicinal Product Labelling: What You Need To Know

Every day we are presented with many different types of labels; from the laundry instructions included on clothing labels to… 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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