Proposed EU standard for stricter medical device approval could prove challenging

The European Union may be moving toward stricter medical device regulations following an implementing act issue in September 2013 by the European Commission. New legislation has been proposed to make approval laws for medical devices the same in all European Union regulatory bodies, and if approved, it will take effect in 2017.

If approved, the new uniform approval process for medical devices will also add time — possibly multiple years — to the approval of a new product, but it would also keep defective products off the market because additional clinical data would be required for approval and this may lead to increased patient safety, sources said.

“A major weakness in the system is there is not much need to demonstrate clinical efficacy or even safety, beyond complying with the (Medical Devices) Directive’s requirements,” Andrew S. Thompson, PhD, a senior medical diagnostic analyst at GlobalData Healthcare, a global research and consulting company, told Orthopaedics Today Europe.

Click here to read the full article in the October Issue of Orthopaedics Today Europe.