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As a manufacturer, you must declare that the medical devices with the CE flags meet the requirements of the medical device directive. UONE has a professional technical as well as rigorous testing and analysis capabilities, which can help you get the approval of the regulatory authorities and ensure product quality and safety.

Medical equipment mainly include：

Blood pressure testing
Biochemical analyzer testing
Blood glucose test instrument detection
Ultrasonic examination equipment testing
Cochlear implants and accessories
Implantable hearing aids
Insulin pump

Implantable infusion pump
Pacemaker system
Retinal implantation
Basic Surgical Instruments
Detection of polymer materials and products
Other medical equipment testing

Worldwide testing standards for medical devices：

Medical Device Directive (MDD 93/42 EEC)
The MDD Directive applies to most medical devices entering the European Union. It is divided into six categories according to different requirements for the certification body assessment.

level	design phase	Production stage
Class I	Self - declaration of conformity	Self - declaration of conformity
Class I (measurement function)	Self - declaration of conformity	Notification Body
Class I (sterilization)	Self - declaration of conformity	Notification Body
Class IIa	Self - declaration of conformity	Notification Body
Class IIb	Notification Body	Notification Body
Class III	Notification Body	Notification Body

EC issued on the medical device products need to meet the following instructions：

Directive Title name	CE Ref.instruction	Examples of products
Active Implantable Medical Devices	90/385/EEC	Cardiac pacemaker
Medical Devices-general	93/42/EEC	Monitor electric wheelchair ECG, ultrasound
Medical devices: in vitro diagnostic	98/79/EC	Urine analyzer Microplate reader Blood glucose meter