Custom-made medical devices
Although many devices are mass produced in factories, there are some instances where the needs of an individual patient or client require customisation. The MDR distinguishes three types of customisation: custom-made devices, modification of existing devices by the care provider and in-house production of devices by a care provider.
In the Netherlands, manufacturers (and their authorised representatives, if applicable) are required to register custom-made devices. This registration obligation has been laid down in Article 2 of the Ministerial regulation
• Please see below for more information on registering custom-made medical devices in NOTIS:
• For more information on registering certain custom-made implantable Class III devices in EUDAMED, as well as reporting incidents, please see the Health and Youth Care Inspectorate website.
Notifying custom-made medical devices
Key documents when submitting a notification
• Registration of your custom-made medical device requires you to upload a declaration. These registrations are not product-specific. Instead, it is possible to use a general format, e.g. a list of categories, which may contain several custom-made medical devices – in other words, a restatement of the declaration excluding individual specifications and specific patient data.
• The declaration must include at least the following:
o name and address of the manufacturer and all production sites;
o name and address of the authorised representative, if applicable;
o means of identification of the device;
o a declaration that the device is exclusively intended for use by a specific patient or user;
o the name of the person issuing the prescription, who was authorised to do so by virtue of their professional qualifications in accordance with national law, and, if applicable, the name of the relevant care facility;
o the specific characteristics of the product as indicated in the prescription;
o an indication that the relevant device complies with the general safety and performance requirements stipulated in Appendix I and, if applicable, a specification of the general safety and performance requirements that are not met in full, stating the reasons for this;
o where applicable, an indication that the device contains or incorporates a medicinal substance, including a human blood or plasma derivative, or tissues or cells, or their derivatives, of human origin, or tissues or cells of animal origin, or their derivatives.
General information for custom-made medical devices
• Custom-made medical devices do not have CE marking. Nor do these devices require a unique identification code (UDI).
• The label of a custom-made medical device must include the wording ‘Custom-made medical device’ (Dutch: Hulpmiddel naar maat).
• Manufacturers of custom-made medical devices must engage a notified body if they manufacture custom-made implantable Class III devices. This group is also subject to mandatory registration in EUDAMED. The government encourages parties to carry out registration through EUDAMED. If you are a Netherlands-based manufacturer or its authorised representative and do not choose this route, you are required to complete a national registration in NOTIS.
Procedure for notifying a custom-made medical device in NOTIS
• Custom-made medical devices are registered in NOTIS by product category, rather than individually. The relevant category is specified in the 'Group name’ field in NOTIS. Due to the current limitations in NOTIS, Risk Class I is only available for selection with the ‘Custom-made’ type. If you select these options,
you will be able to add further details regarding your custom-made medical device in the ‘Short Description’ field.