What is the EU medical device mdd certification? EU medical device mdd certification evaluation

Content related

MDD is the abbreviation of Medical Device Directive. It is a directive under the EU CE certification for medical devices. Products under the MDD directive are divided into three levels: Class I, Class II, and Class III. The higher the hazard level of the product, the higher the level of classification, the stricter the certification, the longer the cycle, and the higher the cost.

Instruction content

1. Active Implantable Medical Devices Directive (AIMD, 90/335/EEC) applies to active implantable medical devices such as pacemakers and implantable insulin pumps. AIMD came into effect on January 1, 1993. The transition deadline was December 31, 1994, and it was enforced from January 1, 1995.

2. In vitro diagnostic device directive (IVD), applicable to in vitro diagnostic medical devices such as blood cell counters and pregnancy detection devices.

3. Medical Devices Directive (93/42/EEC) has a wide scope of application, including almost all medical devices except active implantable and in vitro diagnostic devices, such as passive medical devices (dressings, disposable products, contact lenses, blood bags, catheters, etc.); and active medical devices such as magnetic resonance imaging, ultrasonic diagnostic and therapeutic devices, infusion pumps, etc. The directive came into effect on January 1, 1995, and the transition deadline was June 13, 1998, and it was enforced from June 14, 1998.

The above directive stipulates that after the directive is officially implemented, only medical devices with the CE mark can be sold in the EU market. When selling their products to the EU market, Chinese medical device manufacturers and export companies must comply with the above directive and affix the CE mark, otherwise it will be difficult for their products to enter the EU market.

Submit information

1 Name and address of manufacturer and/or European representative

2Product and model description

3 EC Declaration of Conformity

4. Risk Assessment

5 Basic safety inspection list

6 Applicable blending standards/or other standards

7 Market Feedback and Complaint Analysis

8 Instructions for use and labels

9 Authorized Representative

10 Circuits/diagrams

11 Calculation sheet/test report or other supporting materials

12 Inspection process and process description

13 Sterilization or other special processes (if applicable)

14 Packaging materials and methods for sterilized products

15Quality System/Quality Manual

References

• 1. What does EU medical device MDD certification mean? : Sohu [reference date 2019-09-21T16:00:00.000Z]