Custom-Made Medical Devices in the Netherlands

1. Overview

Custom-made medical devices are tailored for individual patients or clients in the Netherlands, falling under the Medical Device Regulation (MDR). Manufacturers and authorised representatives must register these devices, which do not require CE marking or a Unique Device Identification (UDI). The process involves specific declarations and notifications to ensure compliance with safety and performance requirements. Source: https://english.farmatec.nl/medical-devices/custom-made-medical-devices

2. Definitions

• Custom-made devices: These are devices specifically designed and produced for the unique needs of an individual patient or client. Source: https://english.farmatec.nl/medical-devices/custom-made-medical-devices
• Modification of existing devices: Alterations made by the care provider to adapt standard devices. Source: https://english.farmatec.nl/medical-devices/custom-made-medical-devices
• In-house production: Devices manufactured directly by the care provider for internal use. Source: https://english.farmatec.nl/medical-devices/custom-made-medical-devices

3. Requirements for Notifications

Manufacturers (and authorised representatives, if applicable) are required to register custom-made devices in the Netherlands as per Article 2 of the Ministerial regulation. For custom-made implantable Class III devices, engagement of a notified body is necessary, and registration in EUDAMED is mandatory; however, the government encourages EUDAMED use, otherwise national registration in NOTIS is required for Netherlands-based entities. Custom-made devices must not bear a CE marking and do not need a UDI. The label must include the wording ‘Custom-made medical device’ (in Dutch: Hulpmiddel naar maat). Source: https://english.farmatec.nl/medical-devices/custom-made-medical-devices

4. Documents Needed

A declaration is required for registration, which is not product-specific and can use a general format, such as a list of categories, restating the declaration without individual specifications or patient data. The declaration must include:

• Name and address of the manufacturer and all production sites.
• Name and address of the authorised representative, if applicable.
• Means of identification of the device.
• Declaration that the device is exclusively intended for use by a specific patient or user.
• Name of the person issuing the prescription (authorised by professional qualifications under national law) and, if applicable, name of the relevant care facility.
• Specific characteristics of the product as indicated in the prescription.
• Indication that the device complies with general safety and performance requirements in Appendix I (or specification of requirements not fully met, with reasons).
• Where applicable, indication if the device contains or incorporates a medicinal substance, including human blood or plasma derivative, tissues or cells of human or animal origin, or their derivatives. Source: https://english.farmatec.nl/medical-devices/custom-made-medical-devices

5. Who Must Notify

• Manufacturers of custom-made medical devices.
• Authorised representatives, if applicable. Source: https://english.farmatec.nl/medical-devices/custom-made-medical-devices

6. Process

Registration in NOTIS is done by product category, specified in the 'Group name' field, rather than individually. For Risk Class I, only the ‘Custom-made’ type is available; additional details should be added in the ‘Short Description’ field due to NOTIS limitations. For custom-made implantable Class III devices, register in EUDAMED (preferred) or NOTIS if based in the Netherlands. Source: https://english.farmatec.nl/medical-devices/custom-made-medical-devices

7. Transitional Provisions under MDR

No specific transitional provisions are detailed in the content for custom-made devices beyond general MDR compliance requirements. Source: https://english.farmatec.nl/medical-devices/custom-made-medical-devices

8. Conclusion

The regulation of custom-made medical devices ensures patient-specific solutions meet safety standards without standard certification processes, focusing on tailored declarations and registrations.