When a manufacturer applies for conformity assessment from a notified body (NB), the type of devices and technologies subject to conformity assessment activities are to be indicated using designation codes. After receiving an application, NBs will verify the assignment of codes. Codes are applied to ensure that the NB is able to assess the application based on the NB’s designation, and that it has competent resources to carry out the assessment tasks.
The scope of the designation for an NB can be found from the NANDO database, developed and managed by the EU Commission. Designation codes have been published in the EU Commission implementing act and there are three levels defined for the codes: MDA/MDN, MDS and MDT.
MDA/MDN codes reflect design and intended purpose of device (active device / non-active device). Horizontal codes MDS and MDT reflect the specific characteristics of the device and the technologies/processes needed in device manufacture, respectively. MDS codes are needed only for devices with special characteristics, for example code MDS 1001 is needed if a device incorporates medicinal substances and code MDS 1005 is applicable if a device is sterilized. If identification of the applicable code is challenging, it is worthwhile to check the guidance document published by the Medical Device Coordination Group (MDCG 2019-14).
Identification of all applicable codes is highly important in order to be able to find an NB designated for the type of devices and technologies subject to the conformity assessment activities.
If finding a suitable conformity assessment route or the applicable designation codes is challenging, DRA’s Health Technology team is happy to help your company. Also, if needed, DRA’s Health Technology team will provide support when applying for conformity assessment from an MDR notified body.