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Technical Documentation for EU Medical Device Regulation

Digital Growth Charts Project

  1. Your name and address, or those of any authorised representatives

The Royal College Of Paediatrics and Child Health (RCPCH), 5-11 Theobalds Road, London, WC1X 8SH (telephone: +44 (0)20 7092 6000).

  1. A brief description of the product

  2. Identification of the product, for example, the product's serial number

  3. The name(s) and address(es) of the facilities involved in the design and manufacture of the product

    The product was designed and developed entirely remotely and online using collaboration software.

    The 'place of manufacture' of the product could be most accurately said to be the code collaboration platform GitHub

  4. The name and address of any notified body involved in assessing the conformity of the product

    Not Applicable

  5. A statement of the conformity assessment procedure that has been followed

  6. The EU declaration of conformity

See Declaration of Confomity

  1. Label and instructions of use

All instructions for use are contained within this documentation website.

  1. A statement of relevant regulations to which the product complies

    Regulation (EU) 2017/745 Medical Devices

  2. Identification of technical standards with which compliance is claimed

  3. A list of parts

  4. Compliant parts

  5. Digital Growth Charts Application Programming Interface Server, Version 1

  6. Digital Growth Charts Application Programming Interface React Charting Component, Version 1

  7. Digital Growth Charts Application Programming Interface Demo React Client, Version 1

  8. Digital Growth Charts Application Programming Interface Demo React Native Client, Version 1

  9. Supplementary parts (for which compliance is not claimed)

  10. Test results

    Automated tests on the programs are run on every code change. If the tests fail then the new code cannot be incorporated into the program, and the previous version will remain in place.

    Tests can be viewed in the test/ directory within each repository.

    All repositories are listed at