News & Insights

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

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

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

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

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