News & Insights

Northern Ireland Protocol medical devicesNorthern Ireland Protocol medical devices from Acorn Regulatory

How Will The Northern Ireland Protocol Impact Medical Device Companies?

Our clients have been contacting us in recent weeks with questions relating to the Northern Ireland Protocol and medical devices. … Read more

Most Read MDR Articles of 2020

Acorn Regulatory has been at the forefront of the MDR issue.  While many economic operators across the industry have been… Read more

The Latest Acorn Regulatory Newsletter

November 2020 We have 3 new e-books and guides for you to download in this newsletter. The penultimate newsletter of… Read more

Brexit Northen Ireland Protocol Explained2

How Will The Northern Ireland Protocol Impact Pharma Companies?

How will the Northern Ireland Protocol impact companies in the pharmaceutical sector?  That is a question that we have been… Read more

Regulatory Intelligence 9

Download ‘Regulatory Intelligence 9’ from Acorn Regulatory

‘Regulatory Intelligence 9’ from Acorn Regulatory has a wide range of articles covering issues such as Brexit, the new Medical… Read more

Need a WDA

Do You Need A WDA? Here Is What You Need To Know

There has been an increase in the number of companies that have sought our services to assist them in obtaining… Read more

DCP Closure Acorn Regulatory

How to Move from a DCP Close Out To Product Launch

When a Decentralised Procedure (DCP) or a Mutually Recognised Product (MRP) process is drawing to a close, much of the… Read more

Pharmacovigilance KPIs

Pharmacovigilance KPIs: How They Can Assist You

How important are pharmacovigilance KPIs in the effective management of a PV system?  We look at the issue and look… Read more

Global Access Acorn Regulatory Galway October 2020

Acorn Regulatory To Sponsor Global Access Conference 2020

Acorn Regulatory has announced that it will be one of the Silver Sponsors for the 2020 Global Access Conference hosted… Read more

Brexit guide

The Acorn Regulatory Brexit Guide No. 1 Revised for 2020

We published our first Brexit guide in July 2016.  Back then, we looked at the potential implications for the life… Read more

POST-MARKETING Surveillance

What Are Post-Marketing Surveillance Studies?

Post-marketing surveillance studies are defined in  Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised… Read more

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

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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