The Connected Health & Wellbeing Cluster and dConnect Hub are delighted to partner with Enterprise Ireland on this Health Regulations event that will examine current and future regulations for healthtech and medtech companies, in the EU and the USA.

SMEs in the Healthtech/MedTech world are like adventurers trying to find their way through a complicated maze of regulations in both the EU and US. They’re facing hurdles, trying to meet all the rules and regulations. Our event offers a unique opportunity to delve into the timelines and barriers encountered by SMEs in meeting regulatory requirements, and gain invaluable insights to equip them with essential knowledge and strategies for achieving compliance. Attendees will gain insights into navigating the labyrinth of EU / US market entry, and obtain a better understanding of key considerations by hearing success stories from within the industry.

The new EU Medical Devices Regulation (MDR) aims to improve healthcare through enhanced safety and performance and introduces new technical documentation, as well as clinical data and evaluation requirements.

In the USA, continued regulatory uncertainty on topics ranging from the Affordable Care Act, to Medicare and Medicaid, to changing interoperability regulations, pose serious challenges for healthcare organizations.

Places are limited to 20 companies – register HERE asap

9:30: Coffee

10am: Welcome / Intros

10:15: Overview of EU & FDA Regulatory requirements for Healthtech / MDR – Ceara Treacy, dConnect Hub,

11:15: Artificial Intelligence Regulations – EU / FDA – Ceara Treacy, dConnect

11:45: – Traceability, Regulations, and Healthtech – Robert Kelly, CEO of Heart Rhytym Ireland (HRI), Heart Rhythm Ireland

The EU Medical Devices Regulation (MDR) (EU) 2017/745 has introduced robust new traceability requirements for medical devices, especially Class III implantables. HRI’s barcode scanning and Pro-Link features are designed to empower healthcare providers to seamlessly comply with the EU regulations. HRI have issued over 100,000 credit card-style IDs for cardiac device patients; they are lifelines in emergencies, providing first responders and clinicians with immediate access to critical cardiac device information.

Key MDR traceability highlights:
– The obligation for health institutions to store and maintain the Unique Device Identification (UDI) of Class III implantable devices (Article 27(9)).
– The requirement to provide patients with rapid access to their implant information and an implant card (Article 18(1)).

12:30 Light Lunch / Networking

1:30pm: A Healthtech’s Regulatory Journey – Heikki Pitkänen, CEO & Founder, Lean Entries – Digital Regulatory Runways, Finland. ENTRIES Demo video

– AI Startup Regulatory journey

– Entries Pathway software

– Learnings from working with healthtechs on regulatory journey

– Q&A

ENTRIES guides you through the regulatory principles that need to be understood at the earliest stage of innovation in order to place a medical device, an in vitro diagnostic (IVD) device or any medical software successfully on the market. The tool further helps you determine if the innovation is regulated according to the MDR or the IVDR, and if so, what is the risk class of the device. Based on the device class and type as well as your current status of development ENTRIES generates a personalized draft of a Regulatory Strategy that further guides you with the next steps towards the market entry.

2:15: Panel Discussion – ‘Been there, Done that, Lessons Learned’; Entrepreneurs & Experts

Chaired by Thomas Coleman, Co-Founder of Zendra Health

3:15: Q &A / Open discussion / Next Steps

4pm: Close