Essential Requirements

To acquire the CE marking, all IvD devices must comply with the Essential Requirements (Annex I of the IvD Directive 98/79/EC). The risks involved in using the products must be explained with respect to their intended use and the acceptability of the risks evidenced in the form of a risk analysis.

Likewise, there are regulations with respect to design, manufacture, packaging, labelling and instruction for use of the devices. Special provisions apply for devices for Self-testing, as the use of such devices places particular demands on the device as regards handling and risks. As in the case of other Directives, evidence of the conformity of the device with the Essential Requirements can be provided by means of the harmonised standards (e.g. EN 1441, EN 980, EN 61010) or of the so-called Common Technical Specifications (CTS). The CTS serve in particular as the basis for evaluation and batch assessment Annex II List A Products.