The Unique Device Identifier system applies new requirements on all participants under MDR. Read the blog and find out more about UDI’s.
What Is A Unique Device Identifier?
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What Are Post-Marketing Surveillance Studies?
We look at post-marketing surveillance studies and the link with Risk Minimisation Plans (RMP’s) in this article.
How To Improve The Readability of Package Leaflets
What changes could be made to the readability of package leaflets to make them more accessible for patients? Eileen Shortiss, a Senior Regulatory Affairs Advisor at Acorn Regulatory is our in-house expert on all matters relating to package information leaflets. She...
How To Fix Common eCTD Validation Issues
Previously, we looked at issues that arise within eCTD. Our Publishing Manager, Eileen Ryan, looks at eCTD validation issues in this article. The article looks at Module 1 specification issues and more. We have outlined some additional guidance on eCTD validation...
The 3 Options for eCTD Publishing & Submission Services
This article looks at the three options open to companies when considering how to manage eCTD publishing & submission within their company.
Pharmacovigilance of Medicines for Rare Diseases
We look at the issue of pharmacovigilance for orphan or rare diseases. You can read the article by clicking here.
The FDA Move from Paper to Electronic DMFs
Since May 2019 the US FDA no longer accepts paper formatted DMF’s. The move from paper to electronic reporting continues.
Veterinary Clinical Trials: New EU Law & Global Approaches
There are several ways to approach and perform veterinary clinical trials. Having multiple investigational sites can help overcome potential bias.
How To Fix Complications with UUID Numbers in eCTD
Acorn Regulatory's publishing team is staffed by eCTD experts. We have assisted many companies in their eCTD projects in recent years. Many visitors to our website submit questions on regulatory issues. Issues with UUID numbers arise time and again and we are...
What You Need To Know About Drug Device Combination Products
This drug device explainer looks at the issues concerning combimation products as the sector moves from the MDD to MDR in 2021.
Moving from MDD to MDR? Here Is What You Need To Know
MDR will come into force in 2021. It differs greatly from the MDD. What will the major changes be for medical device manufacturers, importers, and distributors? We look at the major changes in the move from MDD to MDR in this article. What is the MDR? Medical...
How To Write An Effective CER
The MDR introduced has new, stricter criteria for CER (Clinical Evaluation Reports), such as the basis of establishing an equivalence with another device
Update on the EU Authorised Representative & Brexit
This is a June 2020 update on Brexit and the impact on the EU Authorised Representative in light of the UK’s departure from the EU.
Expectations for Human Use Products During The Covid-19 Pandemic
What guidance has been provided to Marketing Authorisation Holders on regulatory expectations and flexibility during the Covid-19 pandemic?
How To Prepare for Remote Audits
We look at how you can prepare for remote audits that might be carried using a virtual technology tool. Click to read the full article.
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