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Conformity Assessment Route for Class I SaMD

UpdatedApril 1, 2025
ByTechnical Team

Introduction

Class I SaMDs represent the lowest risk category within the medical device classification system in the UK. Despite their lower risk profile, these devices must still adhere to specific regulatory requirements before they can be legally marketed.

Self-Certification Process

One of the key advantages of Class I devices is that manufacturers can self-certify their conformity to the UK Medical Devices Regulations 2002 (UK MDR 2002) without mandatory involvement of a UK Approved Body (except in special cases). This self-certification process requires manufacturers to:

  1. Confirm classification as a Class I medical device according to Part II UK MDR 2002 Annex IX
  2. Verify compliance with essential requirements as per Part II UK MDR 2002 Annex I
  3. Conduct clinical evaluation as specified in Part II UK MDR 2002 Annex II
  4. Notify the MHRA of any clinical investigation proposals for a Letter of No Objection
  5. Prepare comprehensive technical documentation
  6. Complete a declaration of conformity
  7. Apply the UKCA mark to the product
  8. Register with the MHRA
  9. Implement and maintain postmarket surveillance and corrective procedures

Special Cases Requiring Approved Body Assessment

While most Class I devices can be self-certified, two specific categories require assessment by a UK Approved Body:

Class I Devices with a Measuring Function

A device is considered to have a measuring function if it:

  • Provides a specific value in a unit of measurement appropriate to the intended purpose
  • The measurement is directly related to patient safety

Examples include:

  • Thermometers
  • Eye tonometers
  • Lung function monitors
  • Syringes with volume indicators

Devices that merely show a change in level or state without indicating a specific value, or indicate values not directly relevant to patient safety, are not considered to have a measuring function.

Class I Sterile Devices

For sterile Class I devices, a UK-approved body must assess the aspects of manufacturing specifically related to securing and maintaining sterile conditions. You can find a list of UK Approved Bodies on the GOV.UK website.

Technical Documentation Requirements

The technical documentation for Class I devices must be comprehensive and maintained for at least 5 years after the last product has been manufactured. Key components include:

  1. Product Description
    • General description including variants, model numbers, and sizes
  2. Materials and Component Documentation
    • Raw material specifications
    • Component drawings
    • Quality control procedures
  3. Final Product Documentation
    • Product specifications
    • Manufacturing methods
    • Quality control procedures
  4. Packaging and Labeling
    • Packaging specifications
    • Labels and instructions for use
  5. Design Verification
    • Test results and design calculations relevant to intended use
  6. Risk Analysis
    • Assessment of risks versus benefits
    • Biocompatibility data where relevant
  7. Essential Requirements Compliance
    • Evidence demonstrating compliance with relevant essential requirements
    • List of applied designated standards
  8. Clinical Evaluation
    • Evaluation of relevant scientific literature
    • Clinical data demonstrating that the device fulfills its intended purpose
  9. Declaration of Conformity
    • Formal declaration that the device meets all applicable requirements

Clinical Evaluation

All Class I devices require a clinical evaluation to demonstrate conformity with essential requirements. This evaluation typically involves:

  • Review of relevant scientific literature
  • Evaluation of available clinical data
  • Assessment of safety and performance in relation to intended purpose

The clinical evaluation must be continually updated with post-market surveillance data after the device enters the market.

Post-Market Surveillance Requirements

Manufacturers must implement robust post-market surveillance activities including:

  • Systematic procedures to review experience gained from marketed devices
  • Mechanisms to implement necessary corrective actions
  • Immediate notification to the MHRA of incidents that:
    • Led to death
    • Led to serious injury or deterioration in health
    • Might have led to death or serious injury
    • Resulted in product recall for technical or medical reasons

For more information on vigilance and incident reporting, visit the MHRA’s vigilance guidance page.

UKCA Marking

The UKCA (UK Conformity Assessed) mark must be applied to Class I devices to indicate conformity with UK MDR 2002 requirements. For devices with measuring functions or sterile devices, the UKCA mark must also include the identification number of the Approved Body that conducted the assessment. For detailed guidance on UKCA marking, refer to the GOV.UK guidance page on using the UKCA marking.

Northern Ireland Considerations

Different rules apply in Northern Ireland, where the CE mark is required instead of the UKCA mark. Class I device manufacturers can self-certify for CE marking, but devices with measuring functions or sterile devices requiring Approved Body involvement must use the CE UKNI marking. Products with the CE UKNI mark cannot be placed on the EU market. For more information, see the guidance on Northern Ireland Protocol.

References

  1. Medicines and Healthcare products Regulatory Agency. (2023). Medical devices: conformity assessment and the UKCA mark. GOV.UK. https://www.gov.uk/guidance/medical-devices-conformity-assessment-and-the-ukca-mark
  2. Medicines and Healthcare products Regulatory Agency. (2022). Guidance on legislation: UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended). GOV.UK. https://www.gov.uk/government/publications/medical-devices-uk-regulations-guidance
  3. National Institute for Health Research. (2023). Software as a Medical Device (SaMD) Regulatory Pathway. NIHR HealthTech Research Centre. https://hrc-devices.nihr.ac.uk
  4. Medical Devices Regulations 2002 (SI 2002 No. 618). Part II, Annex I (Essential Requirements). https://www.legislation.gov.uk/eudr/1993/42/annex/I
  5. Medical Devices Regulations 2002 (SI 2002 No. 618). Part II, Annex IX (Classification Criteria). https://www.legislation.gov.uk/eudr/1993/42/annex/IX
  6. European Commission. (2016). MEDDEV 2.7/1 revision 4 – Clinical evaluation: a guide for manufacturers and notified bodies. https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_guideline_2_7_1_revision_4_en.pdf
  7. European Commission. (2015). MEDDEV 2.1/5 – Medical devices with a measuring function. https://ec.europa.eu/health/sites/default/files/md_sector/docs/meddev_2-1-5_rev_8-1_en.pdf
  8. Medicines and Healthcare products Regulatory Agency. (2023). Register medical devices to place on the market. GOV.UK. https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
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