Medical Device Directive (MDD)
To successfully pass the CE certification of medical device products, three aspects of work are needed.
First, collect European Union technical regulations and European Union (EN) standards related to certified products, and digest, absorb, and incorporate into enterprise product standards.
Second, the enterprise organizes production strictly in accordance with the above product standards, that is, implements the requirements of the above-mentioned technical regulations and EN standards into the entire process of design, development, and manufacturing of the company's products.
Third, enterprises must build and maintain a quality system in accordance with the ISO9000 + ISO13485 standards and obtain ISO9000 + ISO13485 certification.
EU technical regulations and EN standards for medical device CE certification
Regarding the 18 types of industrial product directives currently issued by the European Union, from the structure of these directives, they can be divided into vertical directives and horizontal directives. The vertical directive is targeted at specific products, such as the medical device directive; the horizontal directive is applicable to various product series, such as the electromagnetic compatibility directive, and it applies to all electrical and electronic component products.
For medical devices, there are fourteenth, first, and fifth applicable directives, namely: 93/42 / EEC medical device directive, 73/23 / EEC low voltage (LVD) directive 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 Safety Requirements and No. 1 Amendment;
(3) EN60601-2-11 Medical electrical equipment Part 2: 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 standard electromagnetic compatibility-requirements and tests. The standards (1), (2), and (3) are the basis of the gamma knife low voltage (LVD) test: the standard (4) is the basis of the gamma knife electromagnetic compatibility (EMC) test.
CE certification procedures and contents of medical devices
The European Union classifies 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 and can be declared by themselves. That is, the manufacturer compiles the technical file 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. If the products of Class IIa, Class IIb and Class III are affixed with the CE mark, they must be verified by a certification body designated by the European Union. The European Union also stipulates that the prerequisite for these types of products to obtain CE certification is that the manufacturer must be able to pass the ISO9000 + ISO13485 quality system certification, obtain the ISO9000 + ISO13485 quality system certification certificate, and the issuing unit of the certificate should be a certification body recognized by the EU. The 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.
CE certification procedures and contents for medical devices in the EU are as follows:
1) The enterprise submits the certification application to the certification body, and fills out the certification inquiry form and submits it to the certification body;
2) The certification body submits a quotation to the applicant for certification, and the company signs the confirmation to complete the contract;
3) The enterprise submits the ISO9000 + ISO13485 quality system documents, ie quality manuals and program documents, to the certification body for the certification body to audit the system documents; before the quality system audit, the enterprise shall have at least three months of quality system operation records and complete 1 2 internal quality system audits.
4) The certification body issues a certification product test notice to the testing laboratory accredited by the certification body. The testing laboratory will perform low voltage (LVD) testing and electromagnetic compatibility (EMC) testing on the products applying for certification. If any failure occurs during the test, the enterprise will change the test and retest until it passes the test. After the test is completed, the laboratory issues a test report.
5) The enterprise compiles the technical file archives (referred to as TCF files) of the products 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, and it is an important basis for the certification body to review and issue the certification. All TCF documents must be prepared in English. The TCF file includes seven aspects: ① introduction: ② product specification description; ③ main file content of the design; ④ risk analysis and assessment; ⑤ test report and clinical diagnosis data; ⑥ control of file design; ⑦ product application statement declaration.
6) The certification body conducts a preliminary review of the company's ISO9000 + ISO13485 quality system and TCF documents. After the initial audit, the certification body will point out the problems in the quality system and TCF documents, and the enterprise should improve the quality system and TCF documents accordingly.
7) The certification body formalizes the audit of the company's ISO9000 + ISO13485 quality system and TCF documents.
8) After the formal examination and approval, the certification body will sign a framework agreement with the enterprise, which clearly states that after obtaining the CE certificate, the parties should follow the principles and the scope of the product using the CE mark, and the method of handling complaints. Then issued ISO9000 + ISO13485 quality system certification certificate and CE mark certificate.
Generally speaking, it takes about six months to one year from the application of certification by a company to the issuance of a certificate by a certification body.
Validity of CE mark
Products that have obtained CE certification can be affixed with the CE mark, but only for 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 requires products to obtain CE certification to enter the region Countries and regions. The product CE certification is valid for five years. The CE certificate we obtained this time is because the TCF file submitted is the information of the first generation head gamma knife, so the CE mark can only be affixed to the first generation head gamma knife. If there is a major change in the head gamma knife, the changed documents must be submitted to the CE certification body for recertification, or the CE mark cannot be affixed.
Introduction and classification of medical devices
Introduction
Active implantable medical device (AIMD90 / 385 / EEC)
Any active medical device that is wholly or partly implanted into the human body through surgery or medical methods, or inserted and left in the human body's natural channels.
Medical equipment (MDD93 / 42 / EEC)
Any instrument, equipment, device, material or other article designed by the manufacturer to be used on the human body, either alone or in combination, contains the necessary software to achieve the following:
· Diagnose, prevent, track and treat to reduce disease
Diagnose, track, treat or repair an injury or disability
· Investigation, replacement or trimming during anatomical or physiological processes
·contraception
And these devices should not have pharmacological, immune or metabolic effects, but they can have auxiliary functions.
In vitro diagnostic medical devices (IVDD98 / 79 / EC)
Any reagents, reagent products, calibrators, control materials, kits, instruments, equipment, devices, or systems designed by the manufacturer for use alone or in combination. Derivatives, in vitro test data such as:
-Physiological or pathological state
-Congenital anomalies-Safety and compatibility with patient recipients
-Follow-up treatment
The container of the specimen, whether or not it is in a vacuum form, is particularly regarded as an in vitro diagnostic medical device for the purpose of carrying an in vitro diagnostic test for a specimen from the human body.
For medical products specified in the MDD Directive, the notified body is required to participate in the conformity assessment process. The notified body must meet the requirements of MDD Appendix 11.
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