The Central Europe Free Trade Agreement (CEFTA) National Metrology Institutes (NMIs: IMBiH, INM, ME-BoM) need to be able to correctly implement intraocular-pressure (IOP) metrology regulations in line with a new harmonised approach (e.g. as specified in the Medical Device Regulation (MDR 2017/745)). However, these emerging NMIs are currently unable to fulfil the needs of their national stakeholders in the field of eye-tonometry due a lack of relevant resources and experience. They require an experienced NMI partner to provide them with the necessary knowledge transfer. A Competence Centre for Intraocular pressure (IOP) metrology at CMI will be used to provide the metrological know-how for this purpose and a smart specialisation concept, which was previously designed for IOP metrology in the Central Europe region, will be modified to meet the specific needs of the CEFTA countries (Bosnia and Herzegovina, Moldova and North Macedonia).
The overall objective of this project is to develop a smart specialisation concept in traceable IOP metrology in CEFTA countries.
The specific objectives of the project are:
1. To closely engage with all (minimum 15) major regional legal IOP metrology stakeholders (including responsible state authorities, calibration service providers and other governmental or non-governmental offices), which ensure that legal IOP metrology requirements are met, thus ascertaining the existing and planned IOP metrology calibration services provided in the CEFTA countries as well as their requirements for new IOP metrology calibration services.
2. To provide advanced level metrological training courses at CMI, on IOP measurement, to the staff of IMBiH, INM and ME-BoM (minimum 4 trainees). In addition, to check and adapt the relevant IOP metrology guidelines for use in CEFTA countries.
To develop a smart specialisation concept in traceable IOP metrology in CEFTA countries based on an analysis of the legislation and of the possibilities for mutual cooperation amongst the CEFTA countries.
Early impact on user communities
In the context of the deregulation efforts in EU and CEFTA countries, a large number of private tonometer test and calibration offices were founded, providing a service which was formerly only supplied by governmental offices. However, these private companies rely on the official metrological system for the traceable recalibration of their equipment. The smart specialisation concept will create impact by enabling these small enterprises to have a reliable NMI partner to turn to. This will encourage a more secure and robust industry and it will help to make business more predictable for the serious test offices.
A major additional impact of the project will be the development of an effective communication and cooperation network between the participating NMIs which will allow the metrological partners to stay in close contact with both their customers, public or private test and calibration offices, and legislators and regulatory authorities. This will allow the metrologists to stay up-to-date with the latest developments.
Longer-term economic, social and environmental impacts
This project will establish a smart specialisation concept for IOP metrology in CEFTA countries thus providing a natural starting point and a model strategy for thematically and geographically much wider follow-up projects. The participating NMIs will be able to further develop their expertise and strategies for establishing a sound metrological infrastructure for their MDMFs based on their specific needs. In the longer term, they will be able to transfer this newly acquired knowledge to their regional metrology partners, their stakeholders and into the specific metrology and quality infrastructure framework within their country. Understanding and sharing information on the needs of national stakeholders, such as industrial, healthcare, legislation and regulatory sectors, will create impact and it will be a great platform for future collaboration in the field of the IOP metrology.
More reliable, traceable and accurate calibration methods for eye-tonometers and tonometer test equipment will exist in CEFTA countries. This will improve the acceptance of metrological checks for eye-tonometers and this will provide CEFTA citizens with better, more reliable and less uncertain IOP measurements. As a result, screening for ocular hypertension will become more effective and the results will be more conclusive, thus reducing the misdiagnosis and non-diagnosis rate caused by erroneous eye-tonometry measurements. Hence, fewer healthy individuals will be subjected to unnecessary and potentially harmful treatment and fewer correctly diagnosed individuals will be denied the treatment they require. Thus, medical professionals will be able to treat one of the most important risk factors for glaucoma more effectively. This will improve the quality of life of CEFTA citizens and reduce the burden on their respective healthcare systems.