Essential Requirements
What are the general technical requirements for design and construction to bring my medical device product to the European market?
COUNCIL DIRECTIVE 93/42/EEC
ANNEX I
ESSENTIAL REQUIREMENTS
II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION
10. Devices with a measuring function
10.1. Devices with a measuring function must be designed and manufactured in such a way as to provide sufficient accuracy and stability within appropriate limits of accuracy and taking account of the intended purpose of the device. The limits of accuracy must be indicated by the manufacturer.
10.2. The measurement, monitoring and display scale must be designed in line with ergonomic principles, taking account of the intended purpose of the device.
10.3. The measurements made by devices with a measuring function must be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC.