Medical devices with a measuring function
Medical devices have to provide high level protection for patients and users and to perform at any time according to the characteristics specified by the manufacturer. Therefore, preferential aim of the European directive on medical devices is to ensure the necessary level of protection in all member states of the European Union.
Some medical devices with a measuring function are subject to a change during their use and have therefore to be controlled regularly.
Some medical devices with a measuring function are subject to mandatory verification in Austria. Under Austrian national law the fist time verification of a new measuring instrument is called initial verification. The verification of an unverified instrument is called new verification. The verification during the validity period of the verification is called subsequent verification.
Legal base for dealing with medical devices is in Austria the law on medical devices (Medizinprodukte-gesetz, MPG). This implements nationally the requirements of the European directive on medical devices concerning the placing on the market by the manufacturer and regulates the necessary supervision by state.
For medical devices with a measuring function subject to mandatory verification the CE-marking replaces the initial verification.
This applies for the following measuring instruments:
- Weighing instruments for the determination of mass
As non-automatic weighing instruments they are as well subject to the EU directive 90/384/EEC “Non-automatic weighing instruments” as to one of the two medical devices EU directives 93/42/EEC or 98/79/EC last amended by 2000/70/EC.
- Dosimeters for ionizing radiation (photon or electron radiation), used or maintained in health service.
These are dosimeters for radiotherapy and radiodiagnostics, but not radiation protection dosimeters or dosimeters for constancy tests. The latter are subject to mandatory national type approval and initial verification according to the Metrology Act (MEG).
The new and subsequent verification of the types of measuring instruments mentioned above are subject to national regulations in any case.