Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesEU Authorised RepresentativeIVD DevicesMDD DevicesMDRMedical Devices
Understanding MDR: 8 Important Changes
The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others in the devices sector. The new regulations will bring about many changes compared to the current regulatory framework. We look...
Acorn Regulatory NewsBrian ClearyChristine McGrathEU Authorised RepresentativeGemma RobinsonIndustry NewsPublications
Download ‘Regulatory Intelligence 5’ from Acorn Regulatory
We have published our latest e-book ‘Regulatory Intelligence 5’. This edition features a number of new articles from our expert staff. The articles look at a range of issues, many of the topics were suggested by clients or visitors to...
Acorn Regulatory NewsBrexitBrian ClearyDanica CvetkovicEU Authorised RepresentativeGemma RobinsonPublications
The Risk of No Deal Increases – ‘What Happens Next?’ – The 7th Acorn Regulatory Brexit Whitepaper
The seventh Acorn Regulatory Brexit whitepaper looks at the impact of a no deal departure from the EU on a number of sectors.
Acorn Regulatory NewsAuditEU Authorised RepresentativeHow-To & ExplainersIVD DevicesMDD DevicesMedical Devices
EU Authorized Representative – Find Out What You Need To Know As Brexit Nears
In recent months we have assisted a large number of companies in transferring their EU Authorized Representative from the UK and into another EU country. Companies with an EU Authorized Representative in the UK have been forced to appoint a...
2018’s Most Read Medical Device Articles from Acorn Regulatory
The Acorn Regulatory medical devices team has grown again in 2018 and in the past 12 months we have worked with a wide array of companies from around the world. In that time also, we have written a number of...
Articles from the Archive – In Case You Missed It
Our expert team has written over 300 insightful articles on all aspects of regulatory affairs. Here, we are highlighting some of the best writing from our recent archive in #ICYMI. In this third edition of #ICYMI (In Case You Missed...
The Brexit Newsletter Explained
Our limited series monthly Brexit newsletter will look at the issue of Brexit from a regulatory perspective. The newsletter series will run from September 2018 until the UK’s anticipated departure from the EU in March 2019. Each edition will feature...
What You Need To Know About the EU MDR & The Authorised Representative
Two new EU Regulations entered into force on 26th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR) replace the current three Directives, which have been in place since the early 1990s. There is...
EU MDR: What Will The Impact Be For Economic Operators?
Two new EU Regulations entered into force on 26th May 2017. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in-vitro diagnostics (IVDR) replace the current three Directives, which have been in place since the early 1990s....
#ICYMI 2 – In Case You Missed It – Featured Articles from the Archives
Our expert team has written over 300 insightful articles on all aspects of regulatory affairs. Here, we are highlighting some of the best writing from our recent archive in #ICYMI. In this second edition of #ICYMI (In Case You Missed...
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