Goal
Project goal was to research and determine regulatory strategy to market a mobile medical app as a diagnostic aid to determine level of cognitive functioning.
Background
A European startup company developed a mobile device app known as Standardized Mental Capacity Assessment. This app is intended as a diagnostic aid to determine level of cognitive functioning
and assessing mental capacity. It can be associated with neurodegenerative diseases like dementia, post-brain injury, and developmental disorders.
Objectives
- Determine if app is classified as a medical device
- Determine regulatory pathway to market based on Medical Devices Directive
- Determine applicable legislation that may apply per UK Competent Authority
- Determine cybersecurity regulations
Regulatory Need
Regulatory strategy and pathway to the European market
Activities
- Determine if app is classified as a medical device
- Determine device classification and applicable MDD regulations
- Identify applicable standalone software app lifecycle standards and guidance
- Determine cybersecurity requirements
- Determine clinical study/evaluation requirements
- Determine additional legislation applicable such as Mental Capacity Act 2005
Outcome
Delivered clear, concise roadmap to the EU market
About MAE Group
MAE Group is a business service provider specializing in domestic and international Regulatory Affairs, Clinical Affairs, Quality Systems, Cybersecurity and Networked Security services to healthcare companies to commercialize medical and in vitro diagnostic devices in target markets.
