News & Insights

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 series in advance of the MDR deadline, we are looking at clinical investigations and how… 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

MRP Grouped Variations

What You Need To Know About MRP Grouped Variations

Previously, we have written extensively on the topic of variations.  The topic of MRP Group Variations arises regularly in conversations… Read more

Conformity Assessment Routes Under MDR 2017/745

As part of our ongoing look at the changes being brought about by MDR, we look at Conformity Assessment routes… Read more

Post Market Surveillance part of the Acorn Regulatory series on MDR

Post Market Surveillance under Medical Device Directive (2017/745)

Regulation (EU) 2017/745 on medical devices (MDR) now has increased requirements on specific Post Market Surveillance (PMS) and Post-market clinical… Read more

MDR Whitepaper 3 from Acorn Regulatory

Download the 3rd Acorn Regulatory MDR Whitepaper

The 3rd Acorn Regulatory MDR whitepaper is available now.  This publication looks at Clinical Evaluation Reports, Conformity Assessment Routes and… Read more

Download the latest Acorn Regulatory Publications

Download the latest Acorn Regulatory Publications

Since 2016, the Acorn Regulatory publications on issues such as pharmacovigilance, medical device regulations, Brexit and more.

MDR 2017/745 Importers & Distributors Acorn Regulatory

Six Responsibilities of Importers and Distributors under MDR 2017/745

MDR 2017/745, which comes into force on May 26th, 2020, greatly expands the responsibilities of importers and distributors in comparison… Read more

eCTD Publishing Whitepaper Update

Get The Latest eCTD Publishing Whitepaper Now

Our expert eCTD publishing team has written several whitepapers on issues relating to electronic publishing.  Now, they have compiled the… Read more

Get the MDR newsletter from Acorn Regulatory

Sign Up To Receive Our New MDR Newsletter

Acorn Regulatory will launch a dedicated MDR newsletter in January 2020.  The time-limited MDR newsletter will be published between January… 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.
©2020 Acorn Regulatory Consultancy Services Ltd. Company Registration No. 397294 VAT Registered No. IE 6417294V
Designed by