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  • Medical Devices
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Orthopaedic and dental medical devices

An orthopaedic and dental devices EU Notified Body and UK Approved Body.

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

It is critical to work with an EU Notified Body or UK Approved Body that understands the industry and has the experience to review and confirm your product’s readiness for 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.

Additional resources to support you

  • The safety and performance requirements of medical devices in the European market.

    Find out more
  • Nanomaterials and nanotechnology in medical devices.

    Read more
  • A wide range of free and live webinars.

    Medical Device
Our experts

Meet our experts

Our orthodental Technical & Clinical Specialists have broad industry experience, including product design & development, manufacturing and testing.

  • Chris Wylie, Global Head Orthopaedic & Dental, Regulatory Services, BSI

    "It is a privilege to lead our large team of highly experienced technical experts covering a wide range of orthopaedic and dental devices."

Insights & Media

A wide range of free and live webinars

Hosted by BSI Technical Specialists addressing key topics that affect your business including legislation, risk, and regulatory changes.

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Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, we can help.

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