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
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.
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.
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).
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.
