Towards the Harmonization of Medical Metrology Traceability in Europe: An Impact Case Study Through Activities in Turkey EMPIR Project inTENSE

摘要

The medical metrology activities in Turkey have accelerated in recent years due to the published guidelines and regulations by governmental organizations to set a more homogeneous and regulated scene with respect to the control of medical devices. In this paper, an overview of the current situation in medical metrology activities in Turkey is presented to constitute a case study of metrological checks of medical devices with the largest number device groups subjected to legal checks in Europe, in support of the EMPIR Project inTENSE for Intraocular Pressure – IOP - Metrology. This overview is compared to the legislative framework in the European Union, which is also in a transitional period, and the situation in the EU is presented in contrast: with a harmonized approach for medical devices entering the market, but with heterogeneous regulations with respect to medical devices in the field. After presenting the general situation in EU, the paper considers the metrology in Turkey, medical devices and their control with the active regulations, how medical devices are classified into related authorization groups for the metrological checks and certified training programmes for the medical metrology practitioners, active efforts in public - governmental healthcare facilities and the current situation for tonometers with a conclusion on the ongoing and future activities of the inTENSE project consortium. The efforts of the inTENSE participants in establishing a harmonization of IOP metrology in Central Europe represent the first steps towards a harmonized European medical metrology.