Marie Doyle-Rossi

Marie Doyle-Rossi

Marie Doyle-Rossi’s practice focuses on food and drug law, public and administrative proceedings, European Union law, and product liability and safety.

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MHRA grants second scientific opinion as part of the Early Access to Medicines Scheme

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a second positive scientific opinion as part of the Early Access to Medicines Scheme (EAMS).  EAMS is a UK specific scheme that supports earlier access of unlicensed medicines in patients with seriously debilitating or life threatening conditions where there is an unmet medical need. … Continue Reading

Commission Updates EU Medical Devices Borderline Manual

The European Commission’s Borderline and Classification Medical Devices Expert Group has published a new version of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices.  The updated manual includes a new section on software and mobile applications reflecting the growing industry of medical device software.  The manual also provides new … Continue Reading

International Consensus on “Software as Medical Device” Definition

Last month, the International Medical Device Regulators Forum (IMDRF) reached a consensus on a potentially key aspect of the future regulation of medical software in the US, the EU, Brazil, Canada and Japan, that is, a harmonized definition of when stand-alone software will be considered to be a medical device. This category of software, dubbed … Continue Reading

Commission Recommendation on Unique Device Identification System in the EU

On 5 April, 2013 the European Commission adopted a recommendation on a common framework for a unique device identification (UDI) system in the EU. The hope is that a harmonized UDI system will facilitate device safety monitoring and reporting, recalls and other field safety corrective actions. It will also help avoid device-related medical errors and injuries … Continue Reading
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