As a manufacturer of orthopaedic or dental medical devices, you must ensure that your product meets the relevant regulatory requirements before being placed on the market.
We truly understand the challenges medical devices manufacturers face in bringing compliant products to market efficiently and safely. We offer a range of flexible product review services providing you with efficient pathways to bring your product to market.
Orthopaedic and dental devices are generally characterised as devices intended to treat or reconstruct skeletal or dental tissue.
The scope of orthopaedic and dental devices range from the lowest risk and classification (such as reusable instruments) to the highest risks classification, for example total joint replacements, resorbable devices, orthobiologics and device/drug combination devices.
In addition, total joint replacements of the hip, knee and shoulder are covered under the Commission Supplementary Directive 2005/50/EC.
