Manufacturing & Engineering Product compliance and marking UK-wide

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 9 designated bodies and their scope, when an Approved Body is required, the assessment process by device class, and when self-certification is permitted.

Guide summary

You must choose a UK Approved Body to assess your medical device unless it is Class I (non-sterile, non-measuring), which you can self-certify. Check the body's scope matches your device type and compare at least two bodies on cost and availability. After passing assessment, you get a certificate valid up to 5 years, then affix the UKCA mark.

  • Identify your device class to see if you need an Approved Body
  • Choose a body whose scope covers your device type (Part II, III or IV)
  • Contact at least two bodies to compare fees and availability
  • Submit technical documentation and undergo audit and review
  • Pay £300 registration fee per GMDN category from 1 April 2026
  • Register your device and update changes within 10 working days
  • Keep technical files for at least 10 years after last sale
  • Appoint a UK Responsible Person if you are not a UK manufacturer
  • Renew your certificate before it expires (max 5 years)
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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 (for example, 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.

Several bodies, including BSI Assurance UK Ltd, DEKRA Certification UK Ltd and TUV SUD BABT, are designated across Parts II, III and IV and can assess active implantable devices. Nine UK Approved Bodies are listed; check each body's current designation scope for your device type before applying.

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