Orthopaedic and Dental Medical Devices

Medical Devices Orthopaedic and Dental Devices

Regulatory requirements and compliance for orthopaedic and dental devices are covered under the Medical Devices Directive 93/42/EEC.

As an experienced Orthopaedic and Dental Devices Notified Body, we have a unique skillset to help you reach global markets faster.

What is an orthopaedic and dental device?

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.

A notified body’s perspective on the clinical evaluation requirements under the Medical Device Regulation

jmdr articleUnderstanding of the clinical evaluation process for medical devices against the requirements of the MDR, relevant Medical Device Coordination Group guidance documents is critical for all manufacturers.

Hear from BSI’s Richard Holborow, Head of Clinical Compliance in his recent article in the Journal of Medical Device Regulation on the requirements for clinical evaluation under the MDR from a Notified Body’s perspective and how to meet those requirements.

Download the article >

Regulations for orthopaedic and dental devices

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.

Why choose BSI for your product compliance to Directive 93/42/EEC?

Our solutions are tailor-made for your industry and are delivered by a team of professionals with regulatory, industry and academic expertise. Our dedicated technical experts on our orthopaedic and dental team hold over 40 graduate degrees in a variety of fields.

 

Our team has a combined total of over 200 years experience in the orthopaedic and dental devices sectors. Our technical experts are highly competent and experienced in the development, design, manufacture, and testing of these devices. The range of device expertise and knowledge within the team is diverse. BSI can provide confidence to manufacturers regarding their regulatory and quality compliance, leading to a market advantage.

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