CE CERTIFICATE IN MEDICAL DEVICES
CE Certificate in Medical Devices
Medical device concept by definition; It refers to all kinds of materials, equipment and even software preferred in the diagnosis, prevention and treatment processes of the disease. This concept also includes in vitro devices used for testing purposes. Many medical devices used in this field are subject to the principles 2007/47 / EC published within the borders of the EU. In other words; The devices used in the medical field are obliged to comply with the requirements stated here. The legal requirement for medical devices is quite extensive. In this sense, by providing CE Certificate in Medical Devices, a high level of health protection is provided.
This document, on the other hand; It is also considered a must in terms of performance, safety and quality. The CE mark, located just above the medical devices, indicates that the manufacturer is acting in accordance with legal regulations. There is an impartial assessment of an independent institution that is officially authorized and approved by looking at the product classification. The CE Certificate process in Medical Devices generally consists of separate issues such as security, performance and utility, and monitoring.
In the security aspect; possible risk factors are analyzed in detail. These risks are minimized as a result of the evaluation. Thanks to biocompatibility, the risk of infection is reduced. On the other hand, electromagnetic safety is provided. All safety instructions are again checked in detail and any missing points are reviewed. In the performance dimension; clinical analysis of medical devices. Along with the diagnostic benefit, it is aimed to increase the measurement accuracy.
When manufacturing companies put medical devices on the market, they have to act in accordance with the legal regulations on this issue. Officially approved businesses are audited for verification of quality systems. Producer organizations register for the competent authorities in their country for this. the Ministry of Health in Turkey has brought clarity to this issue under the Medical Device Directive title. Medical devices; it should not harm healthcare professionals, practitioners and third parties in any way. In this respect, it is in no way prevented by the companies that have CE Certificate in Medical Devices offering medical devices to the market. The manufacturer must determine the type of product before obtaining this document. It should also determine what coverage the medical products fall into and act accordingly. Because getting approval about CE mark depends on whether the product meets the directive definition or not.
Is CE Certificate Compulsory?
CE Certificate in Medical Devices includes an ethical responsibility rather than an obligation for manufacturers and certified companies. As it is known, medical devices are divided into certain types according to their risk categories. These; It is expressed as MD, IVD or AIMD. There are serious legislative differences between the United States and the European Union. It is important to classify medical devices correctly in compliance processes.
The CE Certificate required to be used in the use of medical devices is an important regulation created by the EU Commission. This regulation deals with many topics security parameters to shelf life. It is mandatory for businesses to prove that the devices comply with all specified criteria. All the criteria are combined with a technical file. CE Certificate in Medical Devices plays a critical role in terms of the trust and corporate image provided by businesses. All medical devices belonging to the medium or high risk group need this approval. The device manufacturers whose establishment controls are successful are entitled to obtain the relevant document.
It is known that a total of 50 thousand different medical devices are used in health institutions every day. Moreover, the medical device industry is expected to grow by 5% in the coming period. In terms of health, revolutionary changes based on technology should be read correctly in this respect. Medical devices require control as they relate to a sensitive area such as health. These devices seriously affect human life. On the other hand, maintenance and cost costs of the devices are relatively high. The most important changes regarding the legislation take place in 2007. After these changes, compliance with March 2010 is made an imperative.
Which products are within the scope of medical device?
According to the current regulation, there is a universal definition that is accepted in relation to the medical device. According to this;
• Contraception,
• Disease diagnosis, monitoring, treatment,
• Diagnosis, treatment of conditions such as injury or disability,
• Devices manufactured and put on the market for purposes such as researching an anatomical function are evaluated within this scope.
Purpose of CE Certificate in Medical Devices
The main purpose of obtaining this document, which is extremely important and obligatory for medical device manufacturers, is to determine the level of adequacy of the devices before they are put on the market. In this way, the class to which the device belongs is determined and procedures suitable for that class are applied. Finally, protecting public health is one of the main purposes of CE Certificate thanks to the long monitoring process.
As Asan Consultancy, we continue to provide the necessary support to businesses professionally on CE Certificate in Medical Devices, especially within the scope of certification services.
