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  • Medical Devices
    Technical Team

General medical devices

Placing your medical devices on the market.

Placing your general medical device on the market

As a manufacturer of a medical device, you must ensure that you meet the relevant regulatory requirements before placing your product onto 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.

BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme.

What general medical devices cover?

Our team of technical specialists has expertise across all types of medical devices. These are just some of the devices the General team supports:

  • Non active, soft tissue implanted medical device.

  • Wound and skin care medical device.

  • Ophthalmic medical device.

  • Medical devices for infusion and transfusion.

  • MDR Annex XVI medical devices.

  • Other medical devices.

Our Experts

Meet our experts

The challenges presented to manufacturers by the introduction of the EU MDR and UK MDR 2002 are significant.

  • Our Experts

    Neill Bannister, Global Head of General Medical Devices, BSI

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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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