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 busy preparing for implementation in May 2020, there is some uncertainty at present (March 2020) whether this date will be...
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 Device Regulations, DCP Close Outs, and more. The articles in ‘Regulatory Intelligence 9’ have been written by members of our...
Moving from MDD to MDR? Here Is What You Need To Know
MDR will come in to force in 2021. It differs greatly from the MDD. What will the major changes be for medical devices manufacturers, importers, and distributors? We look at the major changes in the move from MDD to MDR...
How To Write An Effective CER
The clock is ticking for medical device manufacturers distributing in the European Union (EU). The EU is transitioning from the Medical Device Directive (MDD) to the new Medical Device Regulation (MDR). The updated European Medical Device Regulation (MDR) introduced in...
Update on the EU Authorised Representative & Brexit
The UK is no longer a member of the European Union. However, until December 31st, 2020 it will be bound by EU legislation. From January 1st, 2021 the UK will be completely outside of the European Union. Negotiations regarding a...
Acorn Regulatory’s Essential Publications
In recent years, we have produced over 25 well-regarded publications. We have looked at topics as diverse as Brexit, CMC, Clinical Trials, Medical Device Regulations and much more. Here, we have compiled a list of the most-read publications for you...
Acorn Regulatory’s Essential Guide to MDR
Acorn Regulatory has been at the forefront of the MDR issue. The Essential Guide to MDR looks at the issue from a range of perspectives. Our expert MDR team has also written several whitepapers on the issue and they can be...
Download ‘Regulatory Intelligence 8’
Edition 8 of the Acorn Regulatory whitepaper series ‘Regulatory Intelligence’ is out now and can be downloaded from our site. This bumper edition looks at a wide range of sectors including: pharmacovigilance, CMC & pharmaceutical, and medical device. In Regulatory...
MDR Delay -Will It Be Postponed?
The Covid-19 crisis has impacted every facet of modern life. The life sciences sector has been at the centre of the crisis as companies have sought to develop a vaccine and ensure that essential supplies are available to those who...
Brexit Regulatory Issues: What You Need To Know
Brexit has been an ever-present issue for professionals in the life sciences sector since 2016. We have worked with many companies in preparing them for the changes that will come from the UK leaving the EU. Here, we have created...
