What are the directives of the European Union medical devices

There are three directives in the field of medical devices in the European Union: (you can consult the China-Russia certification)

1.

Active Implantable Medical Devices Directive (90/385/EEC), referred to as the AIMD, active implantable medical devices are any device that can be implanted in whole or in part in the human body by internal or surgical means, or inserted into a human body orifice by medical treatment, and is intended to be retained in the human body after this process. active medical device in the body.

2.

The Medical Devices Directive (93/42/EEC), or MDD for short, addresses all medical devices and accessories.

3.

The In Vitro Diagnostic Devices Directive (98/79/EC), referred to as the IVDD, which applies to in vitro diagnostic medical devices and accessories such as biochemical differentiators, hematology analyzers, and blood cell counters.

I hope the above explanation can help you. China-Russia Certification