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Latest News

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

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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