Abstract 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 Frame - work 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 require - ments 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.