Medical devices are dedicated products which are used for treatment, cures and applications of the human body. They are typically produced under strict conditions and rigid quality regimes in order to guarantee constant product quality.
The range of products is vast and so is the number of manufacturers. Although many products, especially disposables are produced an imported from outside EU countries we do have the tendency to source regionally, thus in Europe, whenever we can. If this is not possible we are of course committed to finding the most suitable manufacturer elsewhere.
The number of medical devices on the European market is estimated at between 500,000 and a million spread over a total of approximately 8,000 different kinds.
- Medical commodities such as dressing materials, syringes, ECGs etc.
- Medical aids for the disabled, such as wheelchairs
- Medical equipment such as x-ray machines and ultra-sound machines etc.
- Active implants such as heart pacemakers etc.
- Non-active implants such as joint implants or bone screws, medical software such as medical expert systems
- Medical laboratory diagnostics such as HIV tests or pregnancy tests
- Medical laboratory equipment such as laboratory analysers etc.
Medical devices are categorised into three distinct types
- Active implantable medical devices
- General medical devices
- Medical devices for in-vitro diagnosis or in-vitro diagnostic medical devices
The Austrian Medical Devices Act (MPG) and the Medical Devices Operator Regulation (MPBV) regulate the operation of medical devices in health institutions. The following requirements are covered:
- operation in general
- incoming inspection, commissioning, maintenance and application
- periodic safety inspections and metrological checks
- the instruction of the personnel
- the inventory and the device file
- the implant register
- the reprocessing of medical devices