Essential Requirements
What are the general technical requirements to bring my medical device product to the European market?
DIRECTIVE 98/79/EC
(18 June 2009)
ANNEX I
ESSENTIAL REQUIREMENTS
B. DESIGN AND MANUFACTURING REQUIREMENTS
4. Devices which are instruments or apparatus with a measuring function
4.1. Devices which are instruments or apparatus having a primary analytical measuring function must be designed and manufactured in such a way as to provide adequate stability and accuracy of measurement within appropriate accuracy limits, taking into account the intended purpose of the device and of available and appropriate reference measurement procedures and materials. The accuracy limits have to be specified by the manufacturer.
4.2. When values are expressed numerically, they must be given in legal units conforming to the provisions of Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement.