Medical Device Directive (MDD)

To successfully pass CE certification, medical device products need to do three things.

First, collect EU technical regulations and EU (EN) standards related to certified products, through digestion, absorption, and inclusion of corporate product standards.
Second, the company organizes production in strict accordance with the above product standards, that is, the requirements of the above technical regulations and EN standards are implemented in the whole process of design, development and manufacturing of enterprise products.
Third, the company must establish and maintain a quality system in accordance with ISO9000+ISO13485 standards and obtain ISO9000+ISO13485 certification.

EU technical regulations and EN standards for medical device CE certification
For the current 18 categories of industrial product orders issued by the European Union, from the structure of these instructions, they can be divided into vertical instructions and horizontal instructions. Vertical instructions are for specific products, such as medical device instructions; horizontal instructions are applicable to various product lines, such as electromagnetic compatibility directives, which are applicable to all electrical and electronic components.

For medical devices, the applicable directives are Articles 14, 1 and 5, namely: 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 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: Safety requirements for gamma beam therapy equipment;
(4) EN60601-1-2 Medical Electrical Equipment Part 1: Safety General Requirements Section 1.2 Parallel Standard Electromagnetic Compatibility - Requirements and Testing. The criteria in items (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, content
The EU divides medical device products into four categories, namely: Class I, Class IIa, Class IIb, and Class III. For Class I products, the CE mark must be affixed, and the method of self-declaration can be adopted. That is, the manufacturer prepares the technical file of the product, and at the same time, the product is tested according to the relevant EN standard or the competent laboratory is qualified to pass the test. For Class IIa, Class IIb, and Class III products to be CE marked, they must be verified by a certification body designated by the European Union. The EU also stipulates that the prerequisites for CE certification of these types of products are that the manufacturer needs to pass the ISO9000+ISO13485 quality system certification, obtain the ISO9000+ISO13485 quality system certification, and the certificate issuing unit should be the EU-approved certification body. 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 medical device CE certification procedures and contents are as follows:
1) The enterprise submits an application for certification to the certification body, and fills in the certification inquiry form 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 ISO9000+ISO13485 quality system documents, ie quality manuals and procedure documents, to the certification body for the certification of 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 laboratory approved by the certification body. The laboratory will perform low voltage (LVD) test and electromagnetic compatibility (EMC) test on the products to be certified. If the test fails, the company will re-test after the change, until the test is qualified. At the end of the test, the laboratory issued a test report.
5) The enterprise prepares a technical file file (referred to as TCF file) for applying for certification 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 the manufacturer applying for CE certification to the CE certification body. It is an important basis for the certification body to audit and issue certificates. All TCF files must be written in English. The TCF file includes seven aspects: 1 Introduction: 2 product specification description; 3 design main file content; 4 risk analysis and evaluation; 5 test report and clinical diagnosis data; 6 file design control; 7 product application statement declaration.
6) The certification body conducts a preliminary review of the ISO9000+ISO13485 quality system and TCF documents of the enterprise. After the initial review, the certification body will point out the problems in the quality system and TCF documents, and the company should improve the quality system and TCF documents accordingly.
7) The certification body will officially review the ISO9000+ISO13485 quality system and TCF documents of the enterprise.
8) After the formal approval, the certification body will sign a framework agreement with the enterprise. After the CE certificate is obtained, all parties should follow the principle and the scope of the CE mark used by the product, and handle the complaint. Then issued ISO9000 + ISO13485 quality system certification and CE mark certificate.

In general, it takes about six months to one year from the time a company applies for certification to the certification body issuing a certificate.

The validity of the CE mark
If the product has obtained CE certification, it can be marked with the CE mark, but only for the products described in the TCF submitted at the time of applying for certification. The CE mark means that the product can enter the EU market and require the product to obtain CE certification before entering the region. Country and region. Product CE certification is valid for five years. The CE certificate we obtained this time is because the submitted TCF file is the first generation of the head gamma knife, so the CE mark can only be attached to the first generation head gamma knife. If there is a major change in the head gamma knife, the CE document must be submitted to the CE certification body for recertification. Otherwise, the CE mark cannot be affixed.

Introduction and classification of medical devices
Introduction
Active implantable medical equipment (AIMD90/385/EEC)
Any active medical device that is implanted in whole or in part by surgery or medical methods, or inserted and placed in the natural tunnel of the human body.
Medical equipment (MDD93/42/EEC)
Any instrument, device, device, material or other item designed by the manufacturer for use in the human body, alone or in combination, containing the necessary software to achieve the following:
·Diagnosis, prevention, tracking, treatment to alleviate diseases
· Diagnose, track, treat or trim wounds or disability
· Investigation, replacement or trimming during anatomy or physiological processes
·contraception
  And these devices should not have pharmacological, immune or metabolic effects, but can have auxiliary functions.

In vitro diagnostic medical equipment (IVDD98/79/EC)
Any reagent, reagent product, corrector, control material, kit, instrument, device, device, or system designed by the manufacturer, either alone or in combination, for the sole purpose of providing only the specimen, including blood and tissue, human Derivatives, in vitro test data such as:
- physiological or pathological state
- Congenital anomalies - Safety and compatibility with patient receptors
- Measures to track treatment
  The container of the specimen, whether it is in the form of a vacuum or not, especially as a specimen from a human body, intended for in vitro diagnostic testing, is considered to be an in vitro diagnostic medical device.
  In the medical products specified in the MDD Directive, the notified body is required to participate in the conformity assessment procedure. The notified body is required to meet the requirements of MDD Appendix 11.
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