Requirements towards patient care providers

When you fabricate and provide a custom-made device for a patient, you are a manufacturer of custom-made devices and must comply with the following requirements:

  • Draw up a statement according to Annex XIII for the custom-made device and Article 22 for the patient solution.
  • Mark devices as „custom-made device“.
  • Have a person responsible for regulatory compliance (PRRC).
  • Economic operators that devices were received from or supplied to must be identified.

In addition to that, you must implement the following processes:

  • Risk management
  • Clinical evaluation
  • Post-market surveillance (PMS)
  • Vigilance


Risk management

The risk management process requests the creation of a risk management file per patient solution group.

  • The risk management system is a regulatory requirement.
  • The main aspect is to identify hazards with the products and to identify measures for risk control.
  • A risk management file consists of:
    • RM plan
    • Risk analysis and control
    • RM report

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Clinical evaluation

The clinical evaluation is generally applicable to the patient solution.

  • The clinical benefit of a device must be shown based on clinical data.
  • This is a regulatory requirement for each product.
  • Systematic and methodical approach
  • Reproducibility of search and conclusions is very important.

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PMS

PMS requires to plan and document post-production activities.

  • PMS has to be conducted for each product.
  • The activities should follow proactive and reactive approaches.
  • Information from the market has to be collected, evaluated and processed.
  • Continuous safety and performance of products must be ensured.

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Vigliance

Vigilance ensures that problems are identified and communicated as soon as possible.

  • Potential problems with the products must be identified.
  • If necessary, a report to authorities must be issued.
  • Report template has changed (new coding system).
  • Reporting timelines have changed (shortened).
  • It must be investigated whether required field action must be taken (e.g. recall or safety notice).

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Required technical documentation

A manufacturer of custom-made devices must meet the requirements regarding the technical documentation. The technical documentation according to the MDR shall be presented in a clear, organised, readily searchable and unambiguous manner.


Documents for patient file (created and maintained by the MCMD):

  • Patient solution statement
  • General safety and performance requirements checklist
  • Risk management files, at least:
    • Risk management plan
    • Risk analysis
    • Risk management report
  • Clinical evaluation (plan & report)
  • Post-market surveillance documentation
  • Prescription for the custom-made device
  • Information on manufacturing sites
  • Information on quality control
  • Instructions for use
  • Device label

  • Verification documentation (e.g. tests, data sheets, specifications)
    • Biocompatibility
    • Electrical safety
    • etc.


Documents for the patient:

  • A statement containing the following information
    • Name/address of the manufacturer
    • Data for identification of the product
    • Statement that the device is intended for exclusive use by a particular patient or user, identified by name, an acronym or a numerical code
    • Name of the person who made out the prescription and the specific product characteristics
    • A statement that the product is conform with the GSPRs
  • In addition, the manufacturer shall supply all documents to the customer that are necessary to ensure a safe use of the device for a patient. This documents will normally be the following:
    • Instructions for use
    • Device label

Note: The kind of documents in each section are examples and may vary depending on the type of medical device.


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