Medical devices are understood to mean any device, equipment, material and software used in the diagnosis, prevention, monitoring, treatment and mitigation of the disease. The term medical device includes in vitro diagnostic devices used for the examination or improvement of an anatomy or physiological process, or for self-testing in laboratories or by the patient.
All medical devices are subject to the principles of the Medical Devices Directive 2007 / 47 / EC published within the scope of the New Approach Directives within the European Union. In short, all medical devices must comply with the essential requirements of this Directive. Compliance with these comprehensive legal requirements means a high degree of health protection, performance and safety, ie quality for patients, users and third parties collectively.
The CE marking on a medical device means that the manufacturer has manufactured these devices in accordance with the applicable basic requirements. Depending on the classification of the product, a notified body is involved in the assessment process as an independent and impartial body. The identification number of the notified body must therefore accompany the CE marking.
The CE marking ensures that the medical device is manufactured in accordance with the applicable requirements of the directives and national laws. For any medical device, this process is called the conformity assessment process, which includes:
Safety: Risks and side effects are analyzed, evaluated and minimized. Biocompatibility is achieved, infection risk is reduced and eliminated. Electrical, electromagnetic and mechanical safety is provided. Product combinations are allowed or prohibited. Safety instructions are checked to ensure complete and understandable.
Performance and benefit: Clinical or diagnostic evaluation of medical devices is carried out, compliance with specified product specifications is achieved, diagnostic benefit is provided and measurement accuracy is increased.
Monitoring: During the entire life cycle of a medical device, the manufacturer and medical devices are monitored.
Manufacturers, notified bodies and official bodies are responsible for fulfilling the obligations of the CE marking. The manufacturer is responsible for placing a medical device on the market, fulfilling the relevant legal requirements, and informing the competent authorities of any incidents. Notified bodies are responsible for the verification of product and quality systems, as well as independent audit and approval processes for monitoring them. The competent authorities are responsible for ensuring that the requirements of the Medical Device Directive are met. Producers and their authorized representatives are obliged to register with the competent authorities in the country where they are located and to determine the medical devices they put on the market.
In our country, the Medical Device Regulation has been published by the Ministry of Health based on the said directive. Medical devices and accessories should not harm the health and safety of patients, practitioners, users and third parties during use. This regulation specifies the basic requirements of medical devices and accessories and regulates the principles for design, classification, production, placing on the market, commissioning and inspection to ensure protection against various hazards. The placing on the market and putting into service of the medical devices with conformity assessment procedures in accordance with the mentioned regulations cannot be prevented.
Briefly, the CE marking on a medical device is the only element that comes with this product and that it is acceptable to the authorities.
Our company provides medical device CE Certificate services within the scope of certification services. Thanks to these services, enterprises are able to produce more efficient, high performance and quality products in a safe, fast and uninterrupted manner.
Medical device CE Certificate services provided within the scope of certification services are only one of the services provided by our organization in this direction. Many other certification services are also available.