Medical device CE certification standards, the medical CE certification directive has a wide range of applications, including almost all medical devices except active implantable and in vitro diagnostic devices, such as passive medical devices; and active medical devices, Such as nuclear magnetic resonance apparatus, ultrasound diagnosis and treatment apparatus, infusion pump, etc.

To successfully pass CE certification for medical products, three aspects need to be done well.

First, collect EU technical regulations and EU (EN) standards related to certified products, and digest, absorb, and incorporate into enterprise product standards.

Second, the company organizes production in strict accordance with the above product standards, that is, implements the requirements of the above technical regulations and EN standards into the entire process of product design, development and production.

Third, enterprises must build and maintain a quality system in accordance with ISO9000+ISO13485 standards, and obtain ISO9000+ISO13485 certification.

EU technical regulations and EN standards that should be followed for CE certification of medical devices:

For the 18 categories of industrial product directives that have been issued by the European Union, from the perspective of the structure of these directives, they can be divided into vertical directives and horizontal directives. The vertical directive is aimed at specific products, such as the medical device directive; the horizontal directive applies to various product series, such as the electromagnetic compatibility directive, which applies to all electrical and electronic components.

For medical devices, the applicable directives are Item 14, Item 1 and Item 5, namely: 93/42/EEC Medical Device Directive, 73/23/EEC Low Voltage (LVD) Directive 89/336/EEC Electromagnetic Compatibility Sexuality (EMC) Directive.

The EU standards supporting these directives are:

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

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

(3) EN60601-2-11 Medical Electrical Equipment Part II: Special Requirements for the Safety of 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 (1), (2) and (3) are the basis for the Gamma Knife Low Voltage (LVD) test; the standard (4) is the basis for the Gamma Knife Electromagnetic Compatibility (EMC) test.

Medical device CE certification procedures and content:

The European Union divides medical products into four categories, namely: Class I, Class IIa, Class IIb, and Class III. Category Ⅰ products need to be affixed with the CE mark, which can be self-declared. That is, the manufacturer compiles the technical documents of the product, and at the same time tests the product according to the relevant EN standards or entrusts a competent laboratory to pass the test. The products of Class IIa, Class IIb and Class III must be affixed with the CE mark, and must be verified by a certification body designated by the European Union.

The EU also stipulates that the prerequisite for these types of products to obtain CE certification is that the manufacturer must be able to pass ISO9000+ISO13485 quality system certification, obtain ISO9000+ISO13485 quality system certification, and the issuing unit of the certificate should be a certification body recognized by the EU. ISO9000+ISO13485 quality system certification and CE certification can be carried out at the same time, but the CE certificate must be issued after the ISO9000+ISO13485 quality system certification has passed.

Process for CE certification of medical devices:

1. Project application – submit an application for CE certification to the testing agency for supervision.

2. Data preparation – According to the CE certification requirements, the enterprise prepares the relevant certification documents.

3. Product testing – the company sends the samples to be tested to the laboratory for testing.

4. Preparation of reports – certified engineers prepare reports based on qualified test data.

5. Submit for review – the engineer will review the complete report.

6. Issuing a certificate – CE certification will be issued after the report is reviewed and verified.

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