Healthcare & Social Care Product compliance and marking

Choosing a UK Approved Body for medical devices

How to select and engage a UK Approved Body for conformity assessment of your medical device. Covers the 7 designated bodies and their scope, when an Approved Body is required, the assessment process by device class, and when self-certification is permitted.

UK-wide
Guide summary

Check if your medical device needs approval from a UK Approved Body based on its risk class. If it does, choose one of the 7 designated bodies, submit your application with technical documents, and get a certificate to use the UKCA mark.

  • Class I (non-sterile, non-measuring) does not need an Approved Body
  • Class Is (sterile) needs approval for sterility only
  • Class Im (measuring) needs approval for measuring only
  • Class IIa and IIb need full assessment
  • Class III and active implantables need full design and quality checks
  • 7 UK Approved Bodies are available
  • BSI covers all device types
  • Contact bodies for costs and timelines
  • Pay £261 per application
  • Keep records for 10 years
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UK-wide

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UK Approved Bodies are organisations designated by MHRA to conduct conformity assessments for medical devices seeking UKCA marking. Whether you need a UK Approved Body depends on your device's risk class.

When you need a UK Approved Body

  • Class I (non-sterile, non-measuring): Not required. Self-certification by the manufacturer.
  • Class Is (sterile): Required for sterility aspects only.
  • Class Im (measuring): Required for metrological aspects only.
  • Class IIa: Required. Options include product verification, quality system audit, or type-examination.
  • Class IIb: Required. Full type-examination or full quality assurance system audit.
  • Class III: Required. Full design examination and quality system assessment, including clinical data review.
  • Active implantable devices: Required. Full assessment under Part III of the Regulations.
  • IVDs (Annex II List A and B, self-testing): Required.

How to select an Approved Body

Choose your UK Approved Body based on:

  • Scope of designation: Not all bodies cover all device types. Check whether the body is designated for Part II (general medical devices), Part III (active implantable), or Part IV (IVDs).
  • Device specialisation: Some bodies have greater experience with specific device types (e.g. software, implantables, diagnostics).
  • Capacity and timelines: Assessment timelines vary. Contact multiple bodies to compare availability.
  • Cost: Fees are set commercially by each body. Request quotes from at least two bodies.

BSI Assurance UK Ltd is the only body designated for all three Parts (II, III, and IV), making it the only option for active implantable devices. For general medical devices, all seven bodies are available.

The conformity assessment process

The typical process involves:

  1. Submit application to your chosen UK Approved Body with technical documentation
  2. Body reviews documentation and conducts quality system audit (if applicable)
  3. Address any non-conformities raised during assessment
  4. Body issues certificate of conformity
  5. You draw up your UK Declaration of Conformity and affix the UKCA mark with the body's identification number

Certificates are typically issued for a period of up to 5 years and must be renewed before expiry. The UK Approved Body will conduct periodic surveillance audits during the certificate validity period.

UK Approved Body information