Metrology for medical devices

Timeframe

04/2020 - 03/2021

Coordinator/ Submitting institution + WB6 Partners

Beti Vukovojac / Bureau of Metrology/ North Macedonia

General Directorate of Metrology (DPM), Albania
Institute of Metrology of Bosnia and Hercegovina (IMBIH)
Kosovo Metrology Agency (KMA)
Bureau of Metrology, Montenegro

Need for transnational action

Most Medical devices with measuring function in use are not regulated, therefore not metrologically controlled. Capabilities for the control of various instruments are lacking.

Alignment of WB6 countries to the EU Medical Device Regulation (EU) 2017/745.

The health of patients relies on the accuracy of medical instruments. Those medical instruments with measuring functions need to be approved, calibrated and controlled. Metrology plays an important role in this quality chain to ensure the accuracy. There are similar challenges in all WB6 countries so that it is more efficient and effective to address them conjointly.

Objective

The capacities of NMIs for calibration / verification / control of the most relevant types of medical devices with measuring function in WB6 countries are strengthened.

 

Project implementation

1. WB6 Survey on medical devices with measuring function and procedures on their control

2. Workshop for NMI management staff in a WB6 country

3. Implementation of the strategic plan for establishment/ improvement of the metrological capability including study tour for technical staff

4. Implementation of the strategic plan as basis for legislation for control / verification of medical devices with measuring function

5. Closing round table in WB6 country for common resolutions and awareness raising

 

Expected impact

  • Increased competence level for the control of selected medical devices in NMIs and laboratories in charge
  • Increased awareness of decision makers and stakeholders on the importance of traceability in the field of MD and the situation in the participating countries
  • Increased protection level of medical patients due to a wider awareness and implementation of metrological control of MD.
  • WB6 NMIs identified need for further assistance and guidance by international organisations such as EURAMET, WELMEC and OIML.
  • WB6 NMIs identified possible peer-to-peer assistance and complementary set up of services to ensure the quality and comprehensiveness of metrological control of the most relevant medical services.