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)
Processes to be implemented
When acting as a manufacturer of custom-made devices, you need to implement the following four processes:
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
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 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.
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).
Download general process templates here!
The implementation of processes is accompanied by the use of certain documents, which often include a plan and a report suitable for the respective process. We have prepared the necessary documents and standard operating procedures (SOPs) for each process; they are general templates that you can use as a basis for developing your own processes.
However, it is often not possible to apply a single process to all kinds of devices. Therefore we have developed the general templates, which you can download here, into device-specific templates.
The configurator provides you with all necessary process documents as templates for selected device types, e.g. for a leg prosthesis.
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 that must be created and maintained by the manufacturer of custom-made medical devices:
- 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)
- Electrical safety
Documents that must be provided to 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.