How-To & Explainers

Unique device identifier Acorn Regulatory explains

What Is A Unique Device Identifier?

The Unique Device Identifier system under the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on… Read more

GUIDE TO IMPROVING PACKAGE LEAFLET READABILITY

How To Improve The Readability of Package Leaflets

What changes could be made to the readability of package leaflets to make them more accessible for patients?  Eileen Shortiss,… Read more

eCTD validation issues the latest article from Acorn Regulatory

How To Fix Common eCTD Validation Issues

Previously, we looked at issues that arise within eCTD.  Our Publishing Manager, Eileen Ryan, looks at eCTD validation issues in… Read more

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

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

Moving EU Authorised Representative: Find Out How To Move

Does your company currently have an EU Authorised Representative that is based in the United Kingdom?  If so, your company… Read more

Steps to CE Marking an IVD Medical Device

Steps to CE Marking an IVD Medical Device

One of the most frequent questions we are asked is: how do you CE mark an IVD device?  We will… 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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