How do I choose a notified body for medical devices?

Medical devices can be categorized based on MDR (Medical Device Regulation) codes or IVDR (In Vitro Diagnostic Regulation) codes. These codes identify the type of design, intended purpose, characteristics, technologies, processes of the device, or the device use in clinical, laboratory or examination procedures for the device. To become designated as a notified body, organisations must demonstrate competence to these codes. Therefore, notified bodies are only able to conduct conformity assessments for devices and codes they are designated for (i.e. if a notified body does not have the code MDN 1104, they will not be able to assess non-active soft tissue implants). Manufacturers should ensure that the notified body they are engaging with has the appropriate codes needed for their devices. The designation scope of each notified body can be found on the NANDO website.

Additionally, organisations may offer different services. For example, a notified body may be accredited to conformity assess against ISO 13485, but not to the EU MDR or IVDR.