Medical Apparatus And Instruments

Medical Apparatus And Instruments

Medical Apparatus And Instruments

Medical Apparatus And Instruments

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.



Medical device CE certification program, content


The EU classifies medical device products into four categories, namely: category I, category IIa, category IIb, and category III. The first class of products to affix CE mark, can take the form of self-declared. That is, the manufacturer compiles the technical file of the product and at the same time tests the product according to the relevant EN standard or entrusts the competent laboratory to pass the test. Class IIa, Class IIb, Class III products to affix the CE mark, you must verify the certification body designated by the EU. The EU also stipulates that CE certification of these types of products prerequisite for the manufacturer to be able to ISO9000 + ISO13485 quality system certification, obtained ISO9000 + ISO13485 quality system certification, and the issuing unit of the certificate should be recognized by the EU certification body. ISO9000 + ISO13485 quality system certification and CE certification can be carried out at the same time, but the CE certificate must be ISO9000 + ISO13485 quality system certification before being issued.



According to the EU medical device CE certification program and content are as follows:


1) The enterprise submits the application for certification to the certification body and fill in the certification inquiry sheet and submit it to the certification body;

2) The certification body to apply for certification of the company to make a price list, the company signed the contract to confirm the contract;

3) The enterprise submits ISO9000 + ISO13485 quality system documents, ie quality manuals and procedure documents, to the certification body for review by the certification body for the system documents. Before the quality system audit, the enterprise shall have a record of quality system operation for at least three months and complete the 1- 2 internal quality system audit.

4) The certification body issues the certified product test notification form to the laboratory accredited by the certification body. The laboratory will conduct low voltage (LVD) test and electromagnetic compatibility (EMC) test on the certified products. If the test fails, re-test after the company changed, until the test so far. The test is over and the laboratory issues a test report.

5) Enterprises to prepare technical documents for certification products (referred to as TCF file). The above test report is also part of the TCF document. The TCF document is an important document submitted to the CE certification body by the manufacturer applying for the CE certification. It is an important basis for the certification body to audit and certify. TCF documents must be prepared in all English. TCF file includes seven aspects: ¢Ù Introduction: ¢Ú product specifications described; ¢Û design of the main file content; ¢Ü risk analysis and evaluation; ¢İ test reports and clinical diagnostic information; ¢Ş document design control; ¢ß product application statement declaration.

6) The certification body conducts preliminary examination of the ISO9000 + ISO13485 quality system and TCF documents of the enterprise. After the first instance, the certification body will point out the problems existing in the quality system and the TCF document, and the enterprise should improve the quality system and the TCF document accordingly.

7) The certification body formally reviews the ISO9000 + ISO13485 quality system and TCF documents of the enterprise.

8) After the formal examination and approval, the certification body will sign the framework agreement with the enterprise, after the CE certificate is clearly obtained, all parties should follow the principle and the scope of the CE mark of the product and handle the complaint. Then issued ISO9000 + ISO13485 quality system certification and CE mark certificate.


Generally speaking, it takes about six months to a year to apply for certification from a company to a certification body.

CE mark validity


Products have CE certification, you can post the CE mark, but only to apply for certification presented in the TCF described in the product, marked with the CE mark means that the product can enter the EU market and require products to obtain CE certification to enter the area Of countries and regions. Product CE certification is valid for five years. The CE certificate we obtained this time because of the submitted TCF file is the first generation of head gamma knife information, so CE mark only affixed to the first generation of head gamma knife. If there is a major change in the head gamma knife, you must submit the changed document information to the CE certification body for recertification, otherwise, the CE mark can not be affixed.



Introduction and classification of medical devices



Active Implantable Medical Devices (AIMD90 / 385 / EEC)


Any surgical or medical method, implanted in whole or part of the human body, or juxtaposed in the body's natural channel juxtaposition of active medical equipment.

Medical Equipment (MDD93 / 42 / EEC)


Any single apparatus, device, device, material or other article, manufacturer or manufacturer, designed for use on the human body, alone or in combination, shall include the software necessary to achieve the following:

¡¤ Diagnosis, prevention, tracking, treatment to reduce the disease

Diagnose, track, cure or repair injuries or disability

¡¤ Investigation, replacement or trimming of the anatomy or physiology


 And these devices should not have pharmacological, immune or metabolic effects, but may have auxiliary functions.



In Vitro Diagnostic Medical Equipment (IVDD98 / 79 / EC)


Any single agent, reagent product, calibrator, control material, kit, apparatus, device, device, or system designed by the manufacturer for the sole purpose of providing only or mainly the specimen, including blood and tissues, Derivatives, in vitro test data such as:

- Physiological or pathological condition

- Abnormalities - Safety and compatibility with the patient's receptors

- Track treatment measures

 The specimen containers, whether they are in a vacuum form or not, are used as in vitro diagnostic medical devices, especially for the purpose of receiving specimens from the human body and for the purpose of in-vitro diagnostic tests.

 For medical products specified in the MDD Directive, the notified body is required to participate in the conformity assessment procedure. Designated agencies must meet the requirements of MDD Appendix 11.

 Rhine has been approved, meets the requirements of MDD Appendix 11 and is the EU's designated agency.