The Latest Acorn Regulatory Newsletter

January 2021

Happy New Year!  This is the first newsletter of 2021.  The next year will be an important one for the sector; MDR will be introduced in May, while the impact of Brexit will start to be felt from this week onwards as businesses return from their festive break.  We would also like to welcome all of our new subscribers and we hope that all subscribers find the content in these monthly newsletters to be relevant and interesting.  Please feel free to contact us if there is a topic that you would like to see us cover.  Email us with your suggestions.

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Download Our Drug-Device Whitepaper

The new MDR has significantly updated the requirements for medical devices placed on the European market. It has introduced new requirements for manufacturers to comply with to achieve CE marking before placing their products on the European market. Some of the principal changes are in the areas of the role of economic operators, vigilance and post-market surveillance, increased requirements for clinical evidence, and expansion of the scope of products covered under the regulation when compared with the previous directives. This whitepaper provides an overview of the legislative changes, with a focus on the requirements for products that are typically known as drug-device combination products.

Download the guide here.

How Will The Northern Ireland Protocol Impact Medical Device Companies?

Our clients have been contacting us in recent weeks with questions relating to the Northern Ireland Protocol and medical devices.  They are eager to understand the intricacies of the Northern Ireland Protocol and how it will impact their companies.  We have gathered some of the most asked questions and provided answers for them in this guide.

Get access to the publications here.

Clinical Evaluation Report Requirements Under MDR

Regulation (EU) 2017/745 has expanded the requirements related to Clinical Evaluation and Clinical Investigations with Chapter VI (Articles 61 to 82) covering this area.  We take a look at the clinical evaluation report requirements under the MDR to be introduced in May of this year.

Read more here

MDR Regulatory Affairs Consultants

MDR (the medical device regulations) will present the most significant changes in the device sector for a generation.  Our MDR regulatory affairs consultants are ready to assist your company with any issues related to the new regulations.

Read more here

How Will The Northern Ireland Protocol Impact Pharma Companies?

How will the Northern Ireland Protocol impact companies in the pharmaceutical sector?  That is a question that we have been asked many times in recent months.  Now, as the UK’s departure from the EU gets closer, we have created a brief guide on the issue.  The guide answers some of the most commonly asked questions that we have received by email in recent weeks.

Read the whitepaper here.

The Increasing PV Obligations of Scientific Literature

Scientific literature is a significant source of information for the monitoring of the safety profile of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues.
Read the full article here.

MDR Regulatory Affairs Consultants

MDR (the medical device regulations) will present the most significant changes in the device sector for a generation.  Our MDR regulatory affairs consultants are ready to assist your company with any issues related to the new regulations.

Read more here

Acorn Regulatory’s Pharmaceutical Team

Our pharmaceutical regulatory affairs team is staffed by experts who have considerable expertise in the sector.  Every team member has at least 15 years of experience in the pharmaceutical sector assisting pharmaceutical companies with their regulatory issues.  Since 2002, our pharmaceutical regulatory affairs specialists have been working with clients all over the world.

Read more here.