Manufacturers may choose any Notified Body they wish to perform the Conformity Assessment, as long as the Notified Body has the necessary capabilities for the type of device being considered. See the EU Commission’s NANDO system for details of Notified Bodies and their capabilities. Manufacturers also have some flexibility in the conformity assessment route they follow, again depending on the class of their device. See Article 52.
Annex IX contains the conformity assessment route typically chosen by manufacturers who have the capabilities not only to develop a device but also to manufacturer the device and support the device in service. Chapter I describes the procedure for assessing the manufacturer’s quality management system. Chapter II describes procedure for assessing the product’s technical documentation.
If the application is successful, the Notified Body issues an “EU quality management system certificate” (2.3) and an “EU technical documentation assessment certificate” (4.9).
Annex X contains one half of the conformity assessment route typically chosen by manufacturers who choose not to fulfil the quality management system requirements of Annex IX. The manufacturer provides the notified body with the technical documentation, the clinical evidence and, as appropriate, samples of the device for testing. If the application is successful, the Notified Body issues an “EU type-examination certificate” (See 4.).
Annex XI contains two alternative conformity assessment routes which may be used by manufacturers to complement the EU type-examination certificate route of Annex X. According to Part A of the Annex, if the routine production of the device is to be performed under quality management principles, the manufacturer may submit an application for the Notified Body to assess the production quality assurance system. If the application is successful, the Notified Body issues either an “EU quality assurance certificate” (6.3). Alternatively, according to Part B of the Annex, if the production of the device is more bespoke, the manufacturer may apply to the Notified Body to test and verify each produced device. After which the Notified Body issues an “EU product verification certificate” (15.2).
Annex XIII contains the alternative procedures which are to be followed by manufacturers of devices custom made for individual patients.
Deliverables for demonstrating compliance:
(1) An "EU quality management system certificate” for the manufacturer and an “EU technical documentation assessment certificate" for the device.
(2) An “EU type-examination certificate” for the device and either an “EU quality assurance certificate” for the routine production process or an “EU product verification certificate” for bespoke production.
(3) In the case of a custom-made device, the documentation described in Annex XIII.