Introduction to MDD certification:

The MDD (93/42/EEC) certification directive is a mandatory certification for medical device CE certification exported to EU countries. All medical device manufacturers or their authorized representatives shall ensure that medical devices entering the European Economic Area (EEA) must comply with the requirements of this directive.

Scope of MDD certification application:

Including medical equipment and its accessories, any instruments, appliances, equipment, materials, and other items, whether used alone or in combination, including software if necessary; As long as the device is designed for the human body and has the following purposes:

1. Diagnose, prevent, monitor, treat or alleviate diseases,

2. Diagnose, monitor, treat, alleviate or compensate for injuries or disabilities,

3. Investigating, replacing, or modifying anatomical or physiological processes,

4. Pregnancy control,

MDD certification classification:

Medical equipment is classified into different categories and levels according to the Medical Device Directive Guidance Document (MEDDEV 2.4), and each directive has a rule. Based on different requirements, it is divided into 6 levels for certification bodies to evaluate:

1) Class I other 1 Other

2) Class I sterile Class 1 sterilization

3) Class I measurement function: Class 1 measurement

4) Class IIa 2a

5) Class IIb 2b

6) Class III and Class III with medicine Class 3 and Class 3 with medication

Required documents for MDD certification:

The unified evaluation of certification bodies includes reviewing technical documents according to the requirements specified in the directive, evaluating the quality system according to the standard EN46001AK EN/ISO13485, and the required content for medical equipment CE certification technical files:

Product and Model Description

EC Declaration of Conformity

risk assessment

Basic Safety Checklist

Applicable standards/or other standards

Market feedback and complaint analysis

Instructions and labels for use

authorized representative

Calculation sheet, test report or other supporting materials

Inspection process and process description

Sterilization or other special processes (if applicable)

Packaging materials and methods for sterilization products

Quality System, Quality Manual

For specific questions, please consult Zealous Cert Central Certification

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Email： jenniferwang@zealct.com