93/42 / EEC Medical Devices Directive Certification
93/42/ EEC Regulation on Medical Devices covers all kinds of devices, tools, materials or instruments. These materials are presented for the purpose of eliminating or alleviating the disease. When the regulation is examined, it is seen that processes such as treatment, control, diagnosis and monitoring are included. The regulation also focuses on the activities of medical devices led by legal entities or corporate enterprises. Medical devices can be used with medical products from time to time. In this type of situation, an evaluation is made within the scope of the legal legislation.
The purpose of the 93/42/ EEC Medical Devices Regulation is to define the legal qualifications that must be complied with. On the other hand, formally categorizing medical devices into classes and categories is among the purposes of the legislation. All evaluation procedures were determined according to these classes. It is seen that the regulation is carried out sensitively in order to protect public health.
Medical or medical device diagnosis has gained a different dimension with the 93/42/ EEC Medical Devices Regulation. The regulation, which was first introduced, then amended, and finally came into force in 2010, keeps the production, packaging or design of medical devices under control.
Functions of Medical Devices
The functions of medical devices that function depending on various software are as follows:
• Alleviation of the disease at diagnosis, treatment or checkpoint,
• Diagnosis and treatment in cases of injury or disability,
• Control or change of processes related to conception,
• To be able to examine an anatomical situation,
It offers very important advantages for businesses to adhere to compliance laws, both in terms of production and other activities. These; It can be explained as being compatible with the global world, providing privilege in terms of competition, increasing the quality of medical devices and ensuring the quality of service.
Products Excluded from 93/42/ EEC Medical Devices Regulation
• In-vitro diagnostic devices
• Medical products
• Active implantable medical devices
• Tissues or cells of animal origin
• Products made from human blood or tissue
There are some requirements in order to comply with the 93/42/ EEC Medical Devices Regulation and to obtain approval. In this sense, the complete creation of the technical file is the most important issue. Risk assessments and quality systems that include material usage analyzes are included in the assessment. Businesses that respond to quality system needs are entitled to receive the CE mark. Medical devices are divided into several classes depending on their risk and performance. These classes can be described as:
• Class IIa
• Class IIb
• Class III
The relevant ministry closely monitors the controls of medical devices put on the market. If the Ministry detects a negative situation, it makes some legal warnings and regulations. In the warning system, measures are taken in accordance with the class to which the device is connected.
Increase in Medical Devices
Currently, around 50 thousand medical devices can be mentioned in healthcare facilities around the world. Due to the known developments in the last period, medical devices are increasing with a certain acceleration. An increase of around 5% is expected in medical devices in the coming period. Moreover, it is possible to talk about a radical technological transformation in the field of health. Since medical devices are a subject that closely concerns human health, they always require control.
93/42/ EEC Medical Devices Regulation should also be evaluated in this context. With the increase in the importance of medical devices, there has been an increase in the investments made in this field. Medical devices have high costs due to their nature. Some devices may be relatively short-lived. All your problems about the 93/42/ EEC Medical Devices Regulation are easily eliminated with Aşan Danışmanlık. You can get support from Aşan Danışmanlık in the development of medical device evaluation systems. The new regulations made within the framework of the European Union necessitated the implementation of the regulation even more strictly. Accordingly, the way to sell medical device products abroad passes through this standard. This is also very important for manufacturers to protect their corporate image.
The 93/42/ EEC Medical Devices Regulation ensures the safety of patients at all levels. The first studies on the regulation take us back to 1993. The regulation, which aims to harmonize the rules on medical devices, has been developed with updated new versions. Businesses that can define their products as medical devices do not encounter any problems in the European market. Regardless of the subclass related to the product, the technical files must be prepared completely by the manufacturing companies. Above product manufacturers regarding the food in.