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srg36 replied to the topic Classification in FDA Vs EU in the forum EU Regulatory Basics 7 years, 6 months ago
Orthopedic devices such as hip and knee implants are classified in both the US and EU. In the US these devices are considered class II, but I did a little research about how these devices are classified in the EU, and what I found was surprising to me. In 2007 Directive 2005/50/EC was released about the reclassification of hip, shoulder and knee devices. This directive altered the classification of those devices from Class IIb to Class III, giving the following reasons for this reclassification: the hip, knee, and shoulder are complex joints, the hip and knee are weight bearing joints, the hip and knee are extremely sophisticated implants, shoulder implants are a more recent technique, and hip, knee, and shoulder replacement surgery is increasing in younger patients. I found this very interesting, because I expected the classification to be similar or slightly lower in the EU as compared to the FDA, but actually, the EU places these devices in the highest risk class.