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What changes could be made to the readability of package leaflets to make them more accessible for patients? We look at the requirements, the consultations that can be carried out, and the recommendations for improving leaflets. acornregulatory.com/how-to-improve…

Our Repeat Use Procedure slide deck looks at the issues to consider when creating a repeat use procedure. Download it here. acornregulatory.com/download-our-r…

We look at post-marketing surveillance studies and the link with Risk Minimisation Plans (RMP's) in this article. acornregulatory.com/what-are-post-…

Our Publishing Manager, Eileen Ryan, looks at eCTD validation issues in this article. The article looks at Module 1 specification issues and more. acornregulatory.com/ectd-validatio…

This article focuses on what is considered a medical device under MDR 2017/245. Read more here: acornregulatory.com/what-is-a-medi…

This article looks at the three options open to companies when considering how to manage eCTD publishing & submission within their company. acornregulatory.com/the-3-options-…

This article looks at the commonly used strategies for evaluation of post-approval safety and the effectiveness of rare and orphan drugs. acornregulatory.com/pharmacovigila…

In this article we examine the requirements of Post Market Surveillance introduced under MDR acornregulatory.com/post-market-su…

The introduction of the new MDR greatly expands the obligations of Importers and Distributors. This article tells you what you need to know regarding Importers and Distributors responsibilities. acornregulatory.com/responsibiliti…

We look at the requirements of the Unique Device Identifier system under MDR since it's introduction in May, 2021 acornregulatory.com/how-unique-dev…

We have updated this article, one of the most popular on our site. Pharmacovigilance KPIs and how they can assist you. Read the article here. acornregulatory.com/pharmacovigila…

We explore the changes that have arrived since the introduction of MDR in 2021. Read more here:acornregulatory.com/understanding-…

In this article we analyse the increase in requirements and provide a summary of Conformity Assessment Routes. Read more here: acornregulatory.com/conformity-ass…

In the second instalment of our series focusing on the EU Medical Device Vigilance System, we answer the most frequently asked questions we receive from clients. acornregulatory.com/eu-medical-dev…

Our essential guide to understanding MDR provides all you need to know about the new MDR, introduced in May 2021. Read more: acornregulatory.com/mdr-an-essenti…

This article considers 10 questions to ask when moving from a DCP close out to a product launch. Read more: acornregulatory.com/how-to-move-fr…

The new MDR has brought about many changes. This article focuses on the adjustments within Post Market Surveillance that have come about since the introduction of the new MDR. acornregulatory.com/post-market-su…

We look at the requirements of the Unique Device Identifier system under MDR since it's introduction in May, 2021 acornregulatory.com/how-unique-dev…

This article focuses on what is considered a medical device under MDR 2017/245. Read more here:acornregulatory.com/what-is-a-medi…

Our Repeat Use Procedure slide deck looks at the issues to consider when creating a repeat use procedure. Download it here. acornregulatory.com/download-our-r…