News Digital Health Newsletter

MDR, Digital Health deployment in Europe & Regulatory compliance: check highlights of The MedTech Forum & GMTCC

Posted on 28.02.2019

Register now for The MedTech Forum (including GMTCC) and hear from multi-stakeholder panels.

  • MDR – Is the system ready for business? By the time of the MedTech Forum, only 12 months will remain before the Medical Devices Regulation enters into application. How should the medtech industry and the wider community be spending the last remaining months of the transition period? Hear perspectives from representatives of the national competent authorities, the European Commission, hospitals and industry, on how to manage business uncertainties as the regulatory system is still being built.
  • Advancing digital health in Europe’s regions: vision, leadership, investment. Digital health deployments require that people and organisations work together: citizens and patients need to trust the system with their personal data; healthcare providers embrace data to advance diagnosis and treatment; and industry delivers the technologies. But this works only when healthcare authorities set the technical, legal and financial frameworks for the exchange of data. Europe’s regions are the laboratories of change. Find out what has been put in place in the capital region of Denmark, the Styria region of Austria, and in Wales.
  • Regulatory compliance, enforcement and litigation. In the afternoon of 15th May, Scott Danzis (Covington) will be moderating a MedTech Forum/GMTCC panel of MedTech company regulatory lawyers to discuss the interconnection of applicable legal and regulatory requirements for MedTech companies from an international perspective. With today’s regulatory environment in the midst of significant and unpredictable change, driven by a variety of forces including a number of new legislations affecting MedTech companies as well as technological innovation, companies need to actively look for ways to improve the effectiveness and efficiency of their compliance strategies and operations. The discussion will address these aspects, taking into account in particular EU legal requirements, including IVDR/MDR regulation and anti-bribery issues, and comparable U.S. issues, such as compliance with FDA and fraud/abuse issues as well as the interrelationship these legal and regulatory requirements and enforcement trends.

View the full programme on The MedTech Forum website.