An Orthopaedic and Dental Devices EU Notified Body and UK Approved Body

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 and classification, for example total joint replacements, resorbable devices, orthobiologics, device/drug combination devices, just to mention a few.

Regulatory requirements and compliance for orthopaedic and dental devices are covered under the Medical Devices Directive 93/42/EEC. In addition, total joint replacements of the hip, knee and shoulder are covered under the Commission Supplementary Directive 2005/50/EC. This Directive reclassified hip, knee and shoulder joint replacements from Class IIb to Class III.

The Reviewers in the Orthopaedic and Dental team have a wide range of experience from industry, academia and working the medical device regulatory sector.  This in-house expertise and experience makes BSI the Notified Body of choice for the majority of the leading orthopaedic manufacturers.