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

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

Secondly, the enterprise strictly organizes production in accordance with the above product standards, which means implementing the requirements of the technical regulations and EN standards into the entire process of product design, development, and production manufacturing.

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

EU technical regulations and EN standards to be followed for CE certification of medical devices

For the 18 categories of industrial product directives currently issued by the European Union, based on their structure, they can be divided into vertical and horizontal directives. Vertical directives are targeted at specific products, such as medical device directives; The horizontal directive is applicable to various product families, such as the electromagnetic compatibility directive, which applies to all electrical and electronic component products.

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

The EU standards that support these directives are:

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

(2) EN60601-1-1 Medical Electrical Equipment Part 1: General Safety Requirements and First Amendment;

(3) EN60601-2-11 Medical Electrical Equipment Part 2: γ Special requirements for the safety of beam therapy equipment;

(4) EN60601-1-2 Medical Electrical Equipment Part 1: General Safety Requirements Section 1.2 Parallel Standard Electromagnetic Compatibility - Requirements and Testing. The standards (1), (2), and (3) are the basis for Gamma Knife Low Voltage (LVD) testing, while the standards (4) are the basis for Gamma Knife Electromagnetic Compatibility (EMC) testing.

Medical Device CE Certification Procedure and Content

The European Union divides medical device products into four categories, namely Class I, Class IIa, Class IIb, and Class III. Class I products need to be labeled with the CE mark and can be self declared. That is, the manufacturer prepares technical documentation files for the product, and at the same time tests the product according to relevant EN standards or entrusts a capable laboratory to test and pass the test. If Class IIa, IIb, and III products need to be labeled with the CE mark, they must be verified by a verification agency designated by the European Union. The EU also stipulates that the prerequisite for obtaining CE certification for these types of products is that the manufacturing plant must be able to pass the ISO9000+ISO13485 quality system certification, obtain the 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 simultaneously, but the CE certificate must be issued after passing the ISO9000+ISO13485 quality system certification.

According to the EU medical device CE certification procedures and contents, the following are:

1) The enterprise submits a certification application to the certification agency and fills out a certification inquiry form to submit to the certification agency;

2) The certification agency shall submit a quotation to the enterprise applying for certification, and the enterprise shall sign and confirm to complete the contract;

3) Enterprises shall submit ISO9000+ISO13485 quality system documents, namely quality manuals and procedural documents, to the certification body for system document review; Before the quality system audit, the enterprise should have at least three months of quality system operation records and complete 1-2 internal quality system audits.

4) The certification agency shall issue a certification product testing notice to a laboratory recognized by the certification agency, which will conduct low voltage (LVD) testing and electromagnetic compatibility (EMC) testing on the products applying for certification. If there are any nonconformities during the test, the enterprise shall replace them and retest them until they pass the test. After the test is completed, the laboratory will issue a test report.

5) The enterprise prepares a technical document archive (referred to as TCF file) for applying for certification of products. The above test report is also included as one of the contents of the TCF file. The TCF document is an important document submitted by manufacturers applying for CE certification to the CE certification body, and it is an important basis for the certification body to review and issue certificates. All TCF documents must be prepared in English. The TCF file includes seven aspects: ① Introduction: ② Product specification description; ③ The main file content of the design; ④ Risk analysis and assessment; ⑤ Test reports and clinical diagnostic materials; ⑥ Control of document design; ⑦ Declaration of product application.

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

7) The certification agency conducts a formal review of the enterprise's ISO9000+ISO13485 quality system and TCF documents.

8) After the formal review is passed, the certification body will sign a framework agreement with the enterprise, clarifying the principles that all parties should follow after obtaining the CE certificate, the scope of product use of the CE mark, and the handling methods for complaints. Then issue ISO9000+ISO13485 quality system certification certificate and CE mark certificate.

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