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Minister for Health Promotion, Marcella Corcoran Kennedy TD, today opened the Medical Devices Information Day at the Crown Plaza Hotel in Santry.

The event was organised by the Health Products Regulatory Authority (HPRA), which is the competent authority for medicines in Ireland.

The aim of this event was to provide an opportunity for HPRA to outline the finalised content of the new EU-wide regulations for medical devices and in vitrodiagnostic medical devices to industry and other stakeholders.

The Minister spoke of the importance of the medtech industry in Ireland, noting that 18 of the top 25 medtech companies now have operations in Ireland, and employ 29,000 people in over 450 companies. “One of the reasons we have a thriving medical technology industry in Ireland is the country’s excellent reputation as a stable and effectively regulated environment”, the Minister said. She added that good regulation ensures a stable platform for medical technologies to be safely innovated and it paves the way for market access to be achieved in a timely manner.

“The new Regulations are crucial pieces of public health legislation designed to ensure that all medical devices and in vitro diagnostic medical devices placed on the European market are safe for patients and health professionals to use,” Minister Corcoran Kennedy said.

The Minister stated that Ireland played a prominent role in the negotiations of the new Regulations at EU level and contributed to the balanced outcome. The Minister thanked the HPRA for their work in this area. The Minister also thanked Mairéad McGuinness, MEP, for her work on the new Regulations at European Parliament level and said that Ms McGuinness played a significant role in the negotiations.

The Minister pointed out that the Information Day was an important opportunity for industry to gain a deeper understanding of the new regulations and to obtain an initial perspective on national implementation of the new legislative Framework.

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