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...
Acorn Regulatory’s Essential Guide to Brexit
Acorn Regulatory has led the way in providing information and assistance to industry professionals since 2016. We have compiled some of the most read and useful articles in one place to help you to better understand how Brexit will impact...
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...
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...
Carrying Out A Clinical Investigation Under MDR
As part of our ongoing MDR series, we are looking at clinical investigations and how they will operate after the MDR has been introduced. We have written extensively on the MDR issues and at the end of this article, you...
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Medicinal Product Labelling: What You Need To Know
Every day we are presented with many different types of labels; from the laundry instructions included on clothing labels to nutritional information on food and drink packaging, labels are all around us. So what do these different types of label...
Six Responsibilities of Importers and Distributors under MDR 2017/745
MDR 2017/745, which comes into force on May 26th, 2020, greatly expands the responsibilities of importers and distributors in comparison to the current MDD 93/42/EEC. In this article, we look at the responsibilities of the importer and the distributor.
Outsourced eCTD Publishing Services: An Overview
More countries are implementing eCTD. As a result, more companies are being forced to make decisions regarding how they manage their electronic submission and eCTD publishing services. We typically encounter three scenarios: Companies that maintain control of electronic publishing at...
Acorn Regulatory Wins Best Service Provider 2019
Acorn Regulatory won the ‘Best Service Provider’ at the third County Tipperary Business Awards which were held at the Clonmel Park Hotel on Friday, October 18th.
Advice On Supporting Module 1.3.4 Of A Medicinal Product Application
Senior Regulatory Affairs Advisor, Eileen Shortiss, gives advice on supporting Module 1.3.4 of a medicinal product application. This is the latest article in a series written by Eileen that looks at issues relating to labelling, leaflets and SmPC’s.
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