Acorn Regulatory August 2018 Newsletter

Hello and welcome to our August 2018 newsletter. This month we are featuring a new e-book from our ‘Regulatory Intelligence’ series.  We also look at a number of Brexit related issues. Don’t forget that you can subscribe to our new limited run series of Brexit newsletters by subscribing here. The UK’s decision to leave the EU over 2 years ago has convulsed the European political system.  In this edition of the newsletter, we look at the European Medicines Agency’s move to Amsterdam and more.

As ever, we welcome your feedback to info@acornregulatory.com

New EU Medical Device Regulations: The Impact for Economic Operators

Two new EU Regulations entered into force on 26^th 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 a transition period for the implementation of the various elements of the new regulations, with MDR becoming fully operational in May 2021 (following the extension introduced as a result of the Covid-19 crisis) and the IVDR in May 2022. Read more here.  (This article was updated in April 2020 to reflect the changes to the implementation of MDR)

‘Regulatory Intelligence 4’ Available To Download Now  

The latest edition of Acorn Regulatory’s Regulatory Intelligence is available to download now.  In this edition you can read some of the best writing on regulatory issues by our team of experts. Download it here now.

Packing Up & Moving  – The EMA in Amsterdam

The transfer of a manufacturing process or technology from one plant to another within a company can be an arduous process. It involves careful consideration of the impact to the existing site and a rigorous selection process to ensure that the new site is fit for purpose and that there is little interruption to productivity. The 900 staff of The European Medicines Agency are, in many ways, much like the staff of a life science manufacturing firm; highly skilled and large in numbers. Read more about the EMA move here.

Our #ICYMI series has looked at some of the best articles that have been written by members of the Acorn Regulatory team. They also present a good opportunity to bring to your attention articles that you might not have seen before and that might be useful to you.  This edition of the #ICYMI series looks at well-established use, using a US dossier for a European application, how constant changes to legislation and directives can impose additional pressures on regulatory professionals and how new methods of conducting audits can help a company’s bottom line.  Dig deep into the Acorn Regulatory archives here.

Be Prepared for a Hard Brexit

“Be Prepared”  – Robert Baden Powell’s now-famous motto for the Scouting movement seems to be an apt aphorism when considering the possibility of a ‘no deal’ Brexit.  Events and machinations within the UK Government now make the likelihood of such an outcome a distinct possibility.  Therefore companies must ensure that they are prepared for such an outcome. In short, companies must prepare for the possibility that their supply chains and commercial operations will face barriers to trading similar to those that were last experienced almost thirty years ago. Read more here.

Download Our New Brochure

Our new company brochure is available to read and download here. The brochure looks at the wide range of services offered by Acorn Regulatory to companies around the world.

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