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For products to pass CE certification smoothly, three aspects of work need to be done. First, collect EU technical regulations and EU (EN) standards related to the certified products, digest, absorb and incorporate them into the company's product standards. Second, the company strictly organizes production in 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, the company 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 Gamma Knife CE certification

For the 18 types of industrial product directives currently issued by the EU, from the structure of these directives, they can be divided into vertical directives and horizontal directives. Vertical directives are based on specific products, such as medical device directives; horizontal directives apply to various product lines, such as electromagnetic compatibility directives, which apply to all electrical and electronic components.

For the Gamma Knife, 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 and 89/336/EEC Electromagnetic Compatibility (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 2: Special Requirements for Safety of Gamma Beam Therapy Equipment; (4) EN60601-1-2 Medical Electrical Equipment Part 1: General Requirements for Safety Section 1.2 Parallel Standard Electromagnetic Compatibility - Requirements and Tests. Among them, item (1), (2) and (3) are the basis for the Gamma Knife Low Voltage (LVD) test: item (4) is the basis for the Gamma Knife Electromagnetic Compatibility (EMC) test.

Gamma Knife CE Certification Procedure and Content

The EU divides medical device products into four categories, namely: Class I, Class IIa, Class IIb, and Class III. Class I products need to be affixed with the CE mark, which can be done by self-declaration. That is, the manufacturer compiles the technical file of the product, and tests the product according to the relevant EN standards by itself or entrusts a capable laboratory to test it. Class IIa, Class IIb, and Class III products need to be affixed with the CE mark, which must be verified by a certification body designated by the EU. 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 certificate, 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 is passed.

According to the EU's classification of products, the Gamma Knife belongs to Class IIb, and its CE certification procedures and contents are as follows:

1) The enterprise submits an application for certification to the certification body and fills in a certification inquiry form and submits it to the certification body;

2) The certification body submits a quotation to the enterprise applying for certification, and the enterprise signs and confirms to complete the contract;

3) The enterprise submits ISO9000+ISO13485 quality system documents, namely the quality manual and procedure documents, to the certification body for system document review; before the quality system review, the enterprise should have at least three months of quality system operation records and complete 1-2 internal quality system reviews.

4) The certification body issues a certification product test notice to the laboratory recognized by the certification body, and the laboratory will conduct low voltage (LVD) test and electromagnetic compatibility (EMC) test on the product applying for certification. If the test fails, the enterprise will modify it and retest it until the test is qualified. After the test, the laboratory issues a test report.

5) The enterprise prepares the technical document file (TCF file for short) of the product applying for certification. The above test report is also one of the contents of the TCF file. The TCF file is an important document submitted by the manufacturer applying for CE certification to the CE certification body. It is an important basis for the certification body to review and issue certificates. The preparation of TCF documents must be entirely in English. The TCF file includes seven aspects: ① Introduction; ② Product specification description; ③ Main design file content; ④ Risk analysis and evaluation; ⑤ Test report and clinical diagnostic data; ⑥ Document design control; ⑦ Product application declaration.

6) The certification body conducts a preliminary review of the company's ISO9000+ISO13485 quality system and TCF files. After the preliminary review, the certification body will point out the problems in the quality system and TCF files, and the company should improve the quality system and TCF files accordingly.

7) The certification body conducts a formal review of the company's ISO9000+ISO13485 quality system and TCF files.

8) After the formal review is passed, the certification body will sign a framework agreement with the company to clarify the principles that all parties should follow after obtaining the CE certificate and the scope of the product's use of the CE mark, as well as the handling method of complaints. Then issue the ISO9000+ISO13485 quality system certification certificate and CE mark certificate.

Generally speaking, it takes about half a year to a year from the time the enterprise applies for certification to the time the certification body issues the certificate.

Validity of the CE mark 

If the product obtains CE certification, it can be affixed with the CE mark, but it is limited to the products described in the TCF submitted when applying for certification. Affixing the CE mark means that the product can enter the EU market and the countries and regions that require the product to obtain CE certification to enter the region. The validity period of the product CE certification is five years. The CE certificate we obtained this time is because the TCF file submitted is the information of the first generation of head gamma knife, so the CE mark can only be affixed to the first generation of head gamma knife. If there are major changes to the head gamma knife, the changed documents must be submitted to the CE certification body for re-certification, otherwise the CE mark cannot be affixed.

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