Medical device regulation and Big Data

This is an event in the Ideas in Practice series taking place at Leeds University Business School on Monday 16 April 2018

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Medical device regulation and Big Data 

Unique Device Identification (UDI) Systems in Medical Device Regulation – the Role of the GMDN

Leeds University Business School would like to invite you to a talk and networking event on the theme medical device regulation at the time of Big Data. 

Mark Wasmuth (CEO, GMDN Agency) and Dr Barry Daniels (Technical Lead, GMDN Agency) will give a talk about their work on the Global Medical Device Nomenclature as a dynamic yet harmonised system of device classification.

The Global Medical Device Nomenclature (GMDN) is a list of generic names for medical device products used in the diagnosis, prevention, monitoring, and treatment of disease. The main purpose of the GMDN is to provide regulators, health care providers, manufacturers and others with a naming system that can be used to exchange medical device information and support patient safety. The GMDN is a very dynamic classification system, which changes on an almost daily basis as new devices come on the market. The GMDN Agency is the non-profit organisation that is responsible for the ongoing maintenance of the GMDN.

The speakers will focus in particular on their experience of working with the US-American FDA and European counterparts on the implementation of new medical device regulation, including unique device identification (UDI) systems designed to identify devices through distribution and use. They will discuss some of the implications of the introduction of UDI systems for manufacturers, healthcare providers and researchers.

The talk will be followed by an open discussion of regulatory change and the advent of big data in medical device regulation. Ample opportunity will be provided for participants to express their concerns about the forthcoming regulations, with the aim of prioritising areas of highest concern and uncertainty, with a view to influencing policy, funding, future workshops and public-private collaborations.

For more information:

GMDN Explainer video

GMDN Agency

The event is co-hosted by:

• Leeds University Business School
• Centre for Technology, Innovation and Engagement (C-Tie)

Event partners:

• Leeds In Vitro Diagnostics Co-operative
• Leeds Centre for Personalised Medicine and Health

Event format