IVDR Device ClassificationsIVDR 2017/746 outlines 4 different classes A, B, C, D. The A class IVD’s represent the lowest risk and D classified devices represent the highest risk. Classification of IVD devices will take into account the intended purpose of the device and its inherent risks. The majority of IVD’s that require Notified Body Conformity assessment will fall under B and C; a smaller number will fall under Class D, and they will also require Conformity assessment. Class A sterile devices will also require Notified Body conformity assessment. IVD’s that fall under Class A (non-sterile) will not require an under conformity assessment due to their low risk. Annex VIII of the IVDR outlines the Classification rules for IVD devices (Rules 1 to 7).
‘Implementing Rules’Annex VIII also outlines 10 ‘Implementing rules’ which need to be considered before classifying an IVD device. These ‘implementing rules’ include:
- the application of classification rules separately to devices used in combination with each other;
- classification of IVD accessories separately to the device with which they are used,
- and the differentiation between software that drives /influences the use of a device and software that is independent of any other device.
Notified Body Conformity Assessment ProceduresUnder IVDR, for those IVD devices that fall Class A sterile, Class B, C, and D the following Notified Body conformity assessment procedures apply –
- Class A sterile IVDs require an assessment by the NB of the sterile aspects according to Annex IX quality system (or Annex XI production quality assurance).
- Class B IVDs require quality systems (Annex IX). Notified Bodies, as part of an on-site audit, will sample at least one technical file per generic device group (unless these IVD devices are self-testing or near-patient testing, in which case the technical documentation of all devices are required to be assessed)
- Class C devices require either a full quality management system combined with Notified Body review of the technical documentation of at least one device per generic device group (Annex IX) or an EC type-examination (Annex X) together with production quality assurance or EC verification (Annex XI).
- Class D requires the same procedure as Class C, together with batch verification and also the involvement of a reference laboratory (Annex IX)