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98/79/EC In vitro Diagnostic Devices

98/79/EC In vitro Diagnostic Devices
 
Medical Diagnostic Devices Used in In vitro 98/79/EC are medical diagnostic devices that are regulated and inspected in accordance with the European Directive. The production, placing on the market and post-use process of 98/79/EC In vitro Diagnostic Devices, which are included in a subgroup of medical products, are under regular control. We can say that after the 98/79/EC In vitro Diagnostic Medical Devices, which were produced according to the European Directive and put on the market before, they are inspected according to each country´s own inspection rules.

Today, the European Union Commission continues to regularly inspect 98/79/EC In vitro Diagnostic Medical Devices. Thanks to the updates made in usage and production processes after these regular inspections, 98/79/EC In vitro Diagnostic Medical Devices become much more advanced and functional. 98/79/EC In vitro Diagnostic Medical Devices, which are on sale after these inspections, are changed if they are updated.



98/79/EC What are Medical Diagnostic Devices Used In Vitro and What Are Their Features?


According to the 98/79/EC In vitro Diagnostic Medical Devices Directive, we can say that these are test products, test control and statistical products, test calculation products, control materials, control sets, control instruments, control apparatus, equipment and systems.

How and for what purposes 98/79/EC In vitro Diagnostic Medical Devices will be used is also explained in detail within the Directive. These 98/79/EC Medical Diagnostic Devices Used in Extra Body are devices that enable to control how certain reactions in the human body (tissue, blood, urine, etc.) will occur in general terms. In particular, it provides detailed information about diagnosing individual diseases, understanding how the disease progresses, examining the patient´s health status or the course of treatment.

98/79/EC In vitro Diagnostic Devices are used to diagnose the following diseases, to understand how the disease progresses, to examine the health status of the patient or to obtain detailed information about the course of treatment:

- Hepatitis or HIV tests
- Clinical chemistry tests
- Coagulation tests and test systems
- Urine tests and testing equipment
- Pregnancy tests and testing equipment
- Blood glucose measurement systems for diabetes
- Experimental systems and products specially produced for medical experiments



98/79/EC Accessories of In vitro Diagnostic Devices


We can say that among the accessories of 98/79/EC In vitro Diagnostic Devices, there are products that are not included in these devices and are necessary for the use of the devices. These equipments and accessories are also a part of the usage process of the devices. These accessories, which are detailed within the scope of the European Union Commission Directive, are inspected and evaluated separately from the 98/79/EC In vitro Diagnostic Devices.

Devices used for self-testing: Devices or equipment that enable self-testing are a sub-type of 98/79/EC In vitro Diagnostic Devices. These equipment or devices have been specially designed by the manufacturers for users to use in the comfort of their home. These include pregnancy tests.

Performance Evaluation: Devices and equipment to be used for performance evaluation studies are also a sub-type of 98/79/EC In vitro Diagnostic Devices. These devices and equipments are specially produced by the manufacturers. As stated in the European Union Commission Directive, it is more suitable to be used by people who have knowledge on this subject.

There are also equipment and devices specially produced for the use of veterinarians and experts working in the field of animal health. Again, we can say that these are part of the 98/79/EC In vitro Diagnostic Devices. These devices and equipment are suitable for general laboratory use and are not included in the European Union Commission Directive 98/79/EC In vitro Diagnostic Medical Devices, as they are used in the field of animal health. These test products are evaluated within the scope of 93/42/EEC Medical Devices.


98/79/EC Who Produces In vitro Diagnostic Devices?


Manufacturers of 98/79/EC In vitro Diagnostic Medical Devices are legal persons or institutions responsible for design, production, packaging and labeling as stated in the European Union Commission Directive.

The activities of these institutions or individuals, which carry out the entire process with care and in accordance with the auditing rules, are regularly audited. 98/79/EC In vitro Diagnostic Devices are put on the market when they pass the audit successfully. so Be careful when sitting in It is because we attach great importance to this behavior that we attach great importance to it.



98/79/EC Special Requirements for In vitro Diagnostic Devices


98/79/EC Medical Diagnostic Devices for In vitro Use must be in health safety. It cannot be applied in any way. There is no such thing as throwing security applications. It is not necessary to evaluate equipment and installations against these standards.

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