The Irish Medtech Association, the Ibec group that represents the medtech sector, said that the EU Medical Device Regulation coming into full application marks a major milestone.
Medical devices are already subject to a high bar for demonstrating safety, efficacy and clinical benefit, the new EU Regulations further enhances these requirements and strengthens patient protections. The Irish Medtech Association has worked closely with the Irish medtech business industry to help the sector adjust to the change to make it a success.
Irish Medtech Association senior executive Dr Áine Fox added: “For nearly 10 years we have worked with industry and policymakers to bring to fruition the new regulatory system which has been developed to set more stringent requirements for regulatory approval and to enhance patient protections. The EU Medical Device Regulation is replacing the Medical Devices Directive along with the Active Implantable Medical Devices Directive and is a landmark for Ireland’s global medtech hub.
“The Irish medtech sector has invested heavily in changes to business and training staff to progress adherence to the new regulation. However, challenges remain concerning the readiness and capacity of the new system. The need for competent authorities and notified bodies to apply the requirements of the regulation in a harmonised way across EU Member States is also critically important. Without consistent implementation of the new rules, roadblocks will limit the sector’s ability to supply certified devices. This is especially true for start-ups and SMEs which are significant drivers of disruptive innovation in the sector. Our members are committed to the success of the new regulatory regime to ensure that life-changing medical devices developed and manufactured in Ireland continue to reach international markets in a timely manner. We will continue to represent the medtech industry nationally to support effective implementation of the EU Medical Device Regulation.”