by elena@investinu.ie | Aug 6, 2020 | Acorn Regulatory News, Medical Devices
The Unique Device Identifier system under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on all participants of the supply chain with the final aim of improving patient safety through better traceability and transparency....
by elena@investinu.ie | Aug 6, 2020 | Acorn Regulatory News, Medical Devices
The Unique Device Identifier system under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on all participants of the supply chain with the final aim of improving patient safety through better traceability and transparency....
by elena@investinu.ie | Jul 21, 2020 | Acorn Regulatory News, Compliance
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...
by elena@investinu.ie | Jul 13, 2020 | Acorn Regulatory News
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...
