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Ireland’s MedTech sector which has grown exponentially, resulting in Ireland being recognised as one of five global emerging hubs. It is at the forefront of innovation in medical technology that plays a key role in addressing the challenges global healthcare systems face.
The intersection between the development of digital technology in healthcare, the protection and retention of personal data, cyber security, product safety and liability is an increasingly important area for the industry.
The new medical devices regulation (MDR) and in vitro diagnostics medical devices regulation (IVDR) represent a long-awaited strengthening of the existing regulatory system for medical devices in Europe. However, over the coming years, compliance represents a real challenge for the MedTech industry. Our team of regulatory experts is up to speed with the Regulations and ready to assist companies in meeting this challenge.
Examples of matters on which we have acted include, advising:
Our MedTech team prides itself on working with: