China's medical equipment manufacturing enterprises and export company sells its products in the EU market must comply with the EU in the field of medical devices, the European Commission to develop the three EU directives, to replace the original members of the recognition system, so that the delivery of such products coordinated market requirements.

1, active implantable medical device directive (AIMD, 90/335/EEC), applied to cardiac pacemakers, implantable insulin pump and other active implantable medical devices. AIMD in January 1, 1993 came into effect. The transition deadline for December 31, 1994, from January 1, 1995 enforced.

2, in vitro Diagnostic Devices Directive (IVD), applied to blood cell count, and pregnancy testing devices, such as in vitro diagnostic medical devices. The directive is still in the drafting stage, may be in late 1998 or early in 1999 into effect.

3, Medical Devices Directive (MedicalDevicesDirec-tive, 93/42/EEC), the scope is broad, including, inter active implantable and in vitro diagnostic devices outside almost all the medical equipment, medical equipment, such as passive (dressing , a one-time use products, contact lens, blood bags, catheters, etc.); and derived medical devices, such as nuclear magnetic resonance, ultrasound diagnostic and therapeutic equipment, such as infusion pumps. The directive was 1 January, 1995 entry into force of the transition deadline for June 13, 1998 from June 14, 1998 from enforcement.

Add CE mark, otherwise it is difficult to enter the EU market products. In this regard because of my lack of publicity, even though the three of AIMD directive has been enforced for many years, MDD is also on June 14 last year to enforce, but there are a large number of medical device manufacturers and export companies of these requirements very understanding, so this year, China's medical equipment exports will face a severe test. This article introduced the first of these three commands the most extensive in the scope of application of the MDD, the current application for CE mark and should pay attention to some of the problems for a more detailed explanation for the relevant reference.

A, Medical Devices Directive, MDD

MDD is the most European to see the full range of medical equipment requirements of the directive, a total of 23 terms and 12 appendices. An important part of its provisions, including the following:

Provisions of paragraph 1: This directive applies to medical equipment and its annex

Provisions of paragraph 2: Member States must ensure that the delivery and use of its market for medical devices are safe.

Provisions of paragraph 3: the so-called "security" of the equipment should meet the Appendix 1 of the basic requirements.

Provisions of Article 4: CE marked with the medical device can be a free flow in the European Union. Special conditions (Appendix ¢ø and X) allows the use of non-CE marked products and customized clinical research products.

Provisions of Article 5: the coordination of standards in line with the medical equipment is considered to meet the basic requirements.

Article 8: If some kind of unsafe equipment, the provision allowing member states to take action.

Provisions of Article 9: conformity assessment procedures based on the type of product, classification rules set out in Appendix ¢ù.

Provisions of section 11: medical devices must go through a procedure (Procedure ¢ò - ¢÷ described) in order to meet the basic requirements to prove that.

Provisions of Article 17: Meeting the basic requirements and have passed the corresponding conformity assessment procedures with the medical equipment must be CE marked.

Medical Devices Directive requirements may be summarized as follows;

¢Ù All the medical equipment should meet the basic requirements of the Directive.

¢Ú medical equipment in each market before the line with the evaluation procedure should be adopted.

¢Û all have been conducted in line with the corresponding evaluation of medical devices should be marked with CE.

Meet these requirements the responsibility of the manufacturer. Here the so-called "manufacturer" refers to the medical equipment in their own name put on the market of the people, regardless of whether or not he actually produced by others on behalf of its production or sale of the equipment only, the definition of the manufacturer so that only the original sales production companies and not a new situation. In accordance with instructions, manufacturers now they must be met as stipulated in the application instructions to all their obligations.

A. 1 Classification

Medical equipment ranging from plaster to the heart-lung machine, a very broad, it is difficult to have a uniform rule applicable to all the medical equipment. Medical Devices Directive therefore adopted a classification system. It is divided into four categories of medical devices. That is, ¢ñ, ¢ò a, ¢ò b and ¢ó. I-type products also include sterile or have measuring function in the special case of medical devices in general use I * said.

Classification is based on the trauma, the use of time, the use of the site, as well as criteria such as whether or not the energy. Medical Devices Directive in Appendix ¢ù A total of 18 rules of classification criteria can be used as a guidance device. The advantages of the system lies in its "flexibility." For new or rarely used for medical devices are also able to confirm its type, seemingly without a complete list but need to do to amend the medical equipment category.

In order to accurately classify medical equipment manufacturers must determine the intended use of their products. If the product is expected to have several uses, the classification must be one of the highest category. For example, for skin and suture the heart is based on the use of heart to the classification.

A. 2 special procedures

For the two types of medical equipment, that is used for clinical research and medical device customized with special procedures. No CE mark. Medical Devices Directive in Appendix Appendix X ¢ø and description in detail.

A. 3 Conformity assessment procedures

CE directive requirements in the accreditation process as a "conformity assessment procedures." MDD of the compliance evaluation procedures are as follows, according to the classification of products through various channels to prove product meets the basic requirements. Manufacturers can choose the most suited to their requirements.

Appendix ¢÷ MDD compliance evaluation procedures can be carried out by the manufacturers themselves, and notice all the other agencies must be involved in the conformity assessment procedures.

In Appendix ¢ò 3, V and ¢ö described in the corresponding conformity assessment procedures in a quality system, but also with the products. In Appendix ¢ò 4, ¢ó and ¢ô of the procedures described in the pure product.

Notice machinery in accordance with quality system for conformity assessment procedures to assess the manufacturer's quality system. This should be examined by the manufacturer's production plant, if the majority of production in the supplier's production plant, the supplier would also like to review the production plant. Assessment is usually based on ISO9001/2/3 and EN46001 / 2, but also includes the provisions of MDD in a number of special requirements. According to Appendix ¢ò, the system must ensure that the production of equipment in line with the "basic requirements." According to Appendix ¢õ production equipment to ensure that the same sample. According to Appendix ¢ö, the system must ensure that the necessary final inspection.

A. 4 Medical Devices Directive of the basic requirements

Appendix ¢ñ MDD described the basic requirements, including design and structure of the total requirements. Based on anticipated use, the product must meet for their basic requirements. This must be evidenced by the pilot accordingly. Products to meet the basic requirements to satisfy the requirements of the Directive. Meet the requirements of the most simple way is to adopt by the European Standards Committee (CEN) and the European Electric Technology Standards Committee (CENELEC) standards for the development of coordination. CEN and CENELEC standards are mostly developed with reference to international standards. EU non-mandatory standards, since it can also be used to prove that other methods of instruction to meet their basic requirements. However, the coordination of standards for the use of manufacturers will give a great advantage, as long as the manufacturer's product meets the relevant requirements of the coordination of standards, it is that meets the basic requirements. It should be noted that the coordination of the so-called standards, are those in the EU official journal of the European standards promulgated.

MDD of the main contents of the basic requirements are summarized below:

General Requirements

- Must be safe;

- Must be approved in accordance with the current design and manufacturing technology;

- Must be to achieve the desired performance;

- The life of the required products to ensure the safety and performance.

- Must provide for appropriate transportation and storage requirements;

- Side-effects must be within an acceptable range;

- Chemical, physical and biological characteristics, such as: toxic, bio-compatibility, etc. must be within the scope of permissible;

- Infection and microbial contamination must be within an acceptable range;

- A joint role with other equipment, we must consider the environmental conditions (such as EMC, etc.) impact;