NEW EC RULE ADDRESSES HIP, KNEE AND SHOULDER JOINT REPLACEMENTS
The European Commission (EC) reclassified hip, knee and shoulder joint replacements so they will require a higher level of scrutiny by certification organizations before entering the market, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced.
Joint replacements have been reclassified from Class IIb (medium risk) to Class III (high risk). Placing these implants in Class III increases the level of scrutiny that independent third-party certification organizations will have to undertake before issuing a CE mark.
The reclassification came after a request from the MHRA because of concerns about the performance of hip implants. Problems can lead to premature implant failure and early replacement of the artificial joint.
This change is now being implemented across Europe, the MHRA said.