Joint replacements: EC seeks legal basis for upgrade
This article was originally published in Clinica
Executive Summary
The European Commission is now looking into whether there is a legal basis for raising the risk classification for total joint replacements after a majority of EU member states at the Commission's Medical Devices Expert Group meeting on April 7-8 said that they continue to support reclassification. The action to regrade these products from medium-to-high risk to high risk, class IIb to III, is being led by the UK and French authorities (see Clinica No 1053, p 3).