Major milestone marked today with EU Medical Device Regulation application
The Irish Medtech Association, the Ibec group that represents the medtech sector, today marked a major milestone with the EU Medical Device Regulation coming into full application. 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.
Dr Fox added, “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 startups 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.”