‘Regulatory Intelligence 7’ is now available to download. It is the latest edition in our popular series ‘Regulatory Intelligence’.
This article is part of our series of MDR articles that look at the changes coming into play with the… Read more
The Acorn Regulatory Newsletter is read by life science professionals around the world every month. We cover the stories that impact… Read more
As part of our ongoing series in advance of the MDR deadline, we are looking at clinical investigations and how… Read more
Do you have a PSUR Single Assessment (PSUSA) submission deadline approaching? If so, our Regulatory Publishing Manager, Eileen Ryan, has… Read more
Every day we are presented with many different types of labels; from the laundry instructions included on clothing labels to… Read more
We have written extensively on the topic of variations. The topic of MRP Group Variations arises regularly in conversations with… Read more
As part of our ongoing look at the changes being brought about by MDR, we look at Conformity Assessment routes… Read more
Regulation (EU) 2017/745 on medical devices (MDR) now has increased requirements on specific Post Market Surveillance (PMS) and Post-market clinical… Read more
The 3rd Acorn Regulatory MDR whitepaper is available now. This publication looks at Clinical Evaluation Reports, Conformity Assessment Routes and… Read more
Since 2016, the Acorn Regulatory publications on issues such as pharmacovigilance, medical device regulations, Brexit and more.
MDR 2017/745, which comes into force on May 26th, 2020, greatly expands the responsibilities of importers and distributors in comparison… Read more