EU regulators to amend total joint reclassification proposal?
This article was originally published in Clinica
Executive Summary
With industry and regulators still at loggerheads over the joint UK and French authorities' proposal to raise all total joint replacements into a higher risk category, the European Commission's Reclassification Working Party has now worked out a possible compromise. It decided at a meeting on June 24 that its proposal for a Commission Directive on the reclassification of total joint replacements, already drafted, might stand more chance of being adopted without delay and without being caught up if it applied just to total hip, knees and shoulder joints.