How MDR’s Clinical Investigation Rules Could Drive Some Spinal Fusion Products Out Of EU

Clinical evidence requirements set out for class III devices under the EU Medical Device Regulation (MDR) could prove logistically challenging and expensive for the manufacturers of some spinal fusion products, leading to market removals of proven safe and effective products. That is according to a report by consulting firm RMQ+ which has been endorsed by Eurospine, the European society that aims to stimulate the exchange of knowledge and ideas in the field of research, prevention and treatment of spine diseases and related problems.

Requirements set out in the EU MDR’s Article 61 stipulate that class III and implantable devices require clinical investigations.