Medical Device Directive (MDD)

For medical device products to successfully pass the CE certification, three aspects of work need to be done.

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

Second, the company organizes production strictly in accordance with the above product standards, that is, to implement the above technical regulations and EN standards to the entire process of enterprise product design, development and manufacturing.

Third, enterprises must build and maintain quality systems in accordance with ISO9000+ISO13485 standards and obtain ISO9000+ISO13485 certification.

European Union technical regulations and EN standards for medical device CE certification

For the 18 industrial product directives currently issued by the European Union, from the perspective of the structure of these directives, they can be divided into vertical directives and horizontal directives. The vertical directive is aimed at specific products, such as the medical device directive; the horizontal directive is applicable to various product series, such as the electromagnetic compatibility directive, which is applicable to all electrical appliances and electronic parts products.

For medical devices, the applicable directives are the fourteenth, first and fifth, 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 Safety Requirements;

(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 Testing. Among them, items (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.

Medical device CE certification procedures, content

The EU classifies medical device products into four categories, namely: Category I, Category IIa, Category IIb, and Category III. The CE mark shall be affixed to the products of category Ⅰ, which may be declared by itself. 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 commissions a competent laboratory to pass the test. If products with 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 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 European Union. 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 the certification application to the certification body and fills in the certification inquiry sheet to the certification body;

2) The certification body submits a quotation to the company applying for certification, and the company completes the contract after signing and confirming;

3) The enterprise submits the ISO9000+ISO13485 quality system documents, that is, quality manuals and procedure documents, to the certification body for the certification body to review the system documents; 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 body issues a certification product test notice to a laboratory approved by the certification body. The laboratory will conduct low-voltage (LVD) testing and electromagnetic compatibility (EMC) testing on the products applying for certification. If a failure occurs during the test, the company will change it and re-test until it passes the test. At the end of the test, the laboratory issues a test report.

5) The enterprise compiles the technical file file (TCF file for short) of the product applying for certification. The above test report also serves as 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. All TCF files must be written in English. The TCF document includes seven aspects: ①Introduction: ②Product specification description; ③Design main file content; ④Risk analysis and evaluation; ⑤Test report and clinical diagnosis data; ⑥D(zhuǎn)ocument design control; ⑦Product 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 will formally review the company's ISO9000+ISO13485 quality system and TCF documents.

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

Generally speaking, it takes about half a year to a year from the application for certification by the enterprise to the issuance of the certificate by the certification body.

The validity of the CE mark

If the product has obtained CE certification, you can post the CE mark, but only for the products described in the TCF submitted when applying for certification. Pasting the CE mark means that the product can enter the EU market and requires the product to obtain CE certification to enter the region Countries and regions. The product's CE certification is valid for five years. The CE certificate we obtained this time is because the submitted TCF file 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 are major changes to the head gamma knife, you must submit the changed documents to the CE certification body for re-certification, 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 fully or partially implanted in the human body through surgery or medical methods, or inserted and placed in the natural channel of the human body.

Medical equipment (MDD93/42/EEC)

Any instrument, equipment, device, material, or other article designed by the manufacturer to be used on the human body, alone or in combination, contains the necessary software, and is intended to achieve the following conditions:

·Diagnose, prevent, track and treat diseases

·Diagnose, track, treat or repair wounds or disability

·Investigation, replacement or modification during anatomical 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 reagents, reagent products, calibrators, control materials, kits, instruments, equipment, devices, or systems designed by the manufacturer to be used alone or in combination, whose purpose is to provide only or mainly samples, including blood and tissues 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, regardless of whether it is in the form of a vacuum or not, is particularly used as an in-vitro diagnostic medical device for the purpose of carrying out the in-vitro diagnostic test for the specimen from the human body.

 For medical products specified in the MDD Directive, designated institutions are required to participate in conformity assessment procedures. The designated organization must meet the requirements of MDD Appendix 11.

Due to its approval, Le Xun meets the requirements of MDD Appendix 11 and is a qualified designated institution in the European Union.