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90/385 / EEC Active Implantable Medical Devices

90/385 / EEC Active Implantable Medical Devices
 

Materials, which are expressed as medical or medical devices and have a very important place for our health, enable many functions to be fulfilled. Recognition, monitoring, early detection and treatment or alleviation of the disease is the main purpose of these devices. Medical devices, which have a complementary role in treatment processes, have gained a great momentum with the increase in technology.

On the other hand, this type of medical devices have an important function in victimization such as disability and injury. However, it is actively used in research on a physiological function and in birth control processes. All kinds of software, tools, accessories, equipment and all kinds of materials used in order to fulfill their targeted functions without any problems fall into the field of medical devices. Today, it is possible to examine medical devices in three different groups in general terms.
Active Medical Devices: Ultrasound devices or x-ray devices are examples of active medical devices. It works with electrical energy or any power source.

In-vitro Medical Devices: In-vitro actually refers to medical devices used outside the body. Reagents used in pregnancy tests are a suitable sample for in-vitro. In addition, these devices are used to determine blood groups. In recent years, it has been seen that these devices have been used in the sample transport process during the AIDS diagnosis phase. In-vitro medical diagnostic devices have an auxiliary role in infection detection.

Implantable Devices: All or some of the active implantable devices are naturally incorporated into the body as a result of a medical intervention. For example, we can talk about pacemakers or diffusion pumps. Legislation in this field is explained with 90/385 / EEC Active Implantable Medical Devices Regulation. The limited availability of products in the field of medicine at the general level has triggered a competitive environment. In addition, the average lifespan of such medical devices is also low. In order for businesses to carry these products they produce to a valuable market such as the EU, they must fulfill the requirements demanded by the 90/385 / EEC Active Implantable Medical Devices Regulation. We serve as Aşan Consulting during the creation and control of the technical file. Such a consultancy service will give you a great advantage in terms of establishing quality assurance conditions and evaluating product designs.

The said regulation includes all kinds of inspections of public institutions or enterprises regarding the design, manufacture, market supply or use of active implantable medical devices. 90/385 / EEC Active Implantable Medical Devices Regulation aims to eliminate the possible dangers that may arise from the use of the relevant devices by the patients. The principles of placing the products on the market are determined with sharp lines by the 90/385 / EEC Active Implantable Medical Devices Regulation.

Regulation helps protect not only patients but also healthcare workers from danger. As of July 2, 2018, the official process regarding the regulation has been started. Compliance is very important in terms of both production and import notifications. On the other hand, it is obligatory to add the relevant products to the ÜTS by the manufacturers. All details regarding the 90/385 / EEC Active Implantable Medical Devices Regulation have been published together with the Ministry of Health, Turkish Medicines and Medical Devices Agency.


What are the Benefits?


Active implantable medical devices regulation brings very important advantages to businesses. The regulation should be carefully examined in order to protect the corporate image and ensure full compliance with EU legislation. It is possible to list the benefits of complying with the regulation as follows:


• First of all, it ensures that all the requirements are met in order to sell the products in the European market, which is a very important and lively market. This allows you to be in a more solid and protected area in the market against your competitors.
• The quality of active implants increases the sense of trust in the eyes of the customer.
• Medical devices enable participation in a wide and reliable network of experts.


Product Examples


It is possible to talk about many medical devices evaluated within the 90/385 / EEC Active Implantable Medical Devices Regulation. Some of these are as follows:


• Implantable hearing aids,
• Retinal implants,
• Insulin pumps,
• Infusion pumps,
• Pacemaker systems



Conformity Assessment


Businesses optionally participate in a pre-audit. In this process, a broad audit report and analysis is created that includes areas of improvement. Compliance with the plan created before the audit is tested directly on site. All kinds of company audit analysis is done. Compliance with standards is one-time son. These controls involve individuals. Enterprises with positive audits obtain CE markings showing their rights and suitability to certify.

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