Medical Apparatus CE Certification

公司新闻跨境百科法规动态

日期：2026-08-24 点击：32

Medical Device Directive (MDD)

Medical device products to successfully passed CE certification, need to do three aspects of the work.

First, collect EU technical regulations and EU (EN) standards related to certified products, through digestion, absorption, into the corporate product standards.

Second, enterprises in strict accordance with the above product standards organization of production, that is, the above technical regulations and EN standards, the implementation of the enterprise product design and development and manufacturing the entire process.

Third, enterprises must be based on ISO9000 + ISO13485 standard construction and maintenance of quality system, and achieved ISO9000 + ISO13485 certification.

Medical device CE certification should follow the EU technical regulations and EN standards

For the 18 categories of industrial product directives that have been issued by the EU, they can be divided into vertical directives and horizontal directives from the structure of these directives. Vertical directives are for specific products, such as medical device directives; horizontal directives apply to a wide range of product lines, such as electromagnetic compatibility directives, which apply to all electrical and electronic component products.

For medical devices, there are fourteen, first and fifth applicable directives: 93/42 / EEC Medical Device Directive, 73/23 / EEC Low Voltage (LVD) Directive 89/336 / EEC Electromagnetic Compatibility Sex (EMC) directive.

The EU standards that support these directives are:

1) EN60601-1 Medical Electrical Equipment Part 1: Safety General Requirements;

2) EN60601-1-1 Medical Electrical Equipment Part 1: Safety General Requirements and Amendment No. 1;

3) EN60601-2-11 Medical electrical equipment - Part 2: Safety requirements for gamma beam therapy equipment;

4) EN60601-1-2 Medical Electrical Equipment Part 1: General Requirements for Safety Section 1.2 Parallel Standards Electromagnetic Compatibility - Requirements and Testing. Among them, the standards of (1), (2) and (3) are the basis of the LVD test. The standard of (4) is the basis of the Gamma Knife Electromagnetic Compatibility (EMC) test.

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