Step 8: Complete the conformity assessment

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 48.

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” (See 2.4.) and an “EU technical documentation assessment certificate” (See 4.10).

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.).

However, for Companion Diagnostic devices an additional step takes place before the Notified Body can issue the EU type-examination certificate. The Notified Body must first consult with the Authority that approved the associated medicine.

Similarly, there is an additional verification step for Class D devices. The manufacturer must send samples of the device to an EU Reference Laboratory who will independently verify the manufacturer’s performance claims.

Annex XI contains the conformity assessment route that complements the EU type-examination certificate route of Annex X. The manufacturer submits an application for the Notified Body to assess the production quality assurance system. If the application is successful, the Notified Body issues an “EU quality assurance certificate” (See 3.3).

However, for Class D devices an additional production batch verification procedure has to be agreed with the Notified Body (See 5.). It isa requirement for Class D IVDs that the manufacturer sends the test results for each production batch to the Notified Body, together samples from each batch to an EU Reference Laboratory. The EU Reference Laboratory then verifies the manufacturer’s claimed performance to the Notified Body.