MMI is supporting CÚRAM, the Centre for Research in Medical Devices, in its mission to translate research to the clinic and in development and delivery of the centre’s education and training programme.
This partnership is formalised through the SFI funded project entitled: ” Developing Key Structures and Resources to Support Medical Device Clinical Research in Ireland “. As part of this project MMI is assessing the impact of the Medical Device Directive revisions for key stakeholders in the Irish MedTech community.
Medical Writing; Volume 26, Issue 2 (Medical Devices)
New EU medical device regulations: Impact on the MedTech sector
Authors: Robert Behan, Abhay Pandit, Mark Watson
Regulation plays a fundamental role in the translation of innovative medical devices from concept to clinical application and ensures that only devices that exhibit the highest standards of safety and quality are released onto the EU Single Market for sale and clinical use. The impending introduction of a revised Medical Device Regulatory Framework in the EU will require an assessment of how stakeholders in the MedTech sector will be affected. Understanding the impact will be essential for maintaining compliance in the changing regulatory environment as well as for promoting commercial competitiveness and facilitating early access to innovative medical device technologies. In Ireland, a national initiative has been launched to centralise expertise on the regulatory requirements for medical devices in the EU and to analyse how the new medical device regulations will affect requirements for medical device clinical investigations and commercialisation of medical device technologies.
Further information on MMI / CÚRAM Partnership at http://www.crdi.ie/research/curam/