EFGCP Issues Roadmap on Medical Devices


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-04-01-2015
Volume 35
Issue 3

Initiative designed to boost understanding of medical device development in Europe.


The MedTech Europe Medical Technologies Working Party of the European Forum for Good Clinical Practice (EFGCP) has produced a roadmap that is designed to boost understanding of medical device development in Europe.

This initiative is aimed at answering the central question of what constitutes a high quality of clinical evidence for medical technology, in particular from an ethical, patient, clinical, and regulatory perspectives.

"New regulations under consideration in the EU focus on new technologies such as novel in vitro diagnostics (IVDs), companion diagnostics, and on the development of healthcare apps, all of which rely on information to deliver positive health outcomes," noted the EFGCP in a statement. "Gathering clinical evidence and knowing when and how to conduct clinical investigations for these new technologies is a challenge which still needs to be addressed."

The Working Party is determined to address these open questions and investigate the generation of clinical evidence for IVDs, companion diagnostics, and healthcare apps from the point of view of clinicians, patients, regulators, and product developers. To start the process, it is organizing a multi-stakeholder workshop on establishing best practices in clinical development of devices in this area. Called "Barriers and Pathways to Success," the event will take place in Belgrade, Serbia, May 7-8 at the Chamber of Commerce and Industry of Serbia.

This will be followed by a two-day workshop on "Ethics, Quality and Oversight in the Clinical Development of Medical Devices," to be held at University College London June 15-16. The Working Party is organizing another workshop on risk management and regulation at the Central Hospital of Luxembourg in October, and then a roundtable on combination drug/device products in Leiden, Netherlands, in January 2016. "A constructive and energetic year is planned, to make sure the medical technology sector has its own spotlight and that concrete solutions are found for the well-being of patients," said EFGCP chair Ingrid Klingmann, MD.

For more information, visit www.efgcp.eu.

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