Classification

Article 47 requires all IVDs to be classified into one of four classes. The classification determines the conformity assessment route for the device. While classification is primarily the concern of the manufacturer, if the device falls into Classes B, C or D it has implications for the Notified Body. Article 47 confirms that if a Manufacture and Notified Body cannot agree on the classification, the Competent Authority of the Manufacturer is the body that makes the final determination.

Before attempting to classify any device, it is recommended to first develop the following documented statements required for the Technical Documentation (Annex II, 1.1):

(a) … a general description of the device including its intended purpose and intended users;

(c) the intended purpose of the device which may include information on: (i) what is to be detected and/or measured; (ii) its function such as screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic; (iii) the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate; (iv) whether it is automated or not; (v) whether it is qualitative, semi-quantitative or quantitative; (vi) the type of specimen(s) required; (vii) where applicable, the testing population; (viii) the intended user; (ix) in addition, for companion diagnostics, the relevant target population and the associated medicinal product(s).

(d) the description of the principle of the assay method or the principles of operation of the instrument;

Annex VIII contains the rules to be followed to determine the classification of the device and the two chapters are intended to be read and applied in sequence. Therefore, referring as necessary to the documents (a), (c) and (d) listed above, perform the following steps:

1. Start by reviewing the Implementing rules (Chapter I): For example, is the device intended to be used in combination with another device? This is particularly relevant question for software.
2. Then read through the Classification rules (Chapter II). There are seven Classification rules. Work through the classification rules step by step in order to arrive at a classification that best describes to the device under consideration.

Finally, it is important to document the decision on the classification and the supporting justification. It is another required item in the Technical Documentation (Annex II, 1.1):

(f) the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII;