Measuring Instruments

For medical devices with a measurement function the devices must comply with the SI 2002-618 as amended

MEASURING INSTRUMENTS DIRECTIVE 2014/32/EU remains in force until 31/12/2021

Background, Scope and Compliance

Compliance of measuring instruments has been brought together under a directive which originally came into force on 30 October 2006. The following categories of measuring instrument are included:

1. water meters
2. gas meters
3. active electrical energy meters
4. heat meters for measuring heat given up by liquids in a heat exchange circuit
5. measuring systems for continuous and dynamic measurement of quantities of liquids
other then water
6. automatic weighing instruments
7. taximeters
8. material measures
9. dimensional measuring instruments and
10. exhaust gas analysers

Annexes MI 001 to M010 specify the precise definition of each category and the route to compliance. These Annexes all refer to the Essential Requirements of the MID but also add category specific Essential Requirements which must be complied with.

Compliance is by meeting one of the specific routes to compliance defined in the MI annexes and by meeting all the Essential Requirements that apply to that category of measuring device. Note that other Directives such as the PED, the LVD and the EMC Directive may also apply to certain measuring instruments.