News & Insights

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

The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) 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 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

We have written extensively on the topic of variations.  The topic of MRP Group Variations arises regularly in conversations with… 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

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