European Union to eliminate trade barriers among member countries, and gradually establish a unified market, to ensure that personnel, services, capital and products (such as medical devices) in free circulation. In medical devices, the European Commission developed a three EU directives, to replace the original members of the accreditation system, so that the provisions of such products to market harmonization.
These three commands are:
1. Active Implantable Medical Devices Directive (AIMD, 90/335/EEC), applied to cardiac pacemakers, implantable insulin pumps and other active implantable medical devices. AIMD on January 1, 1993 to take effect. Transition deadline of December 31, 1994, from January 1, 1995 to enforce.
(2) in vitro diagnostic devices directive (IVD), for Cytometer, pregnancy testing devices, in vitro diagnostic medical devices. The directive is still in draft stage, may be in late 1998 or early 1999 into effect.
3 Medical Devices Directive (Medical Devices Direc-tive, 93/42/EEC), applicable to a wide range, including in addition to active implantable and in vitro diagnostic devices than almost all of the medical equipment, medical equipment, such as passive (dressings, disposable products, contact lenses, blood bags, catheters, etc.); as well as derived medical devices, such as nuclear magnetic resonance, ultrasound diagnostic and therapeutic equipment, infusion pumps. The directive was January 1, 1995 effective transition deadline June 13, 1998 from June 14, 1998 from enforcement.
The directive provides that, in the formal implementation of the Directive, only CE marked medical device products to the EU market.
China's medical device manufacturer and exporter of its products are sold in the EU market must comply with the provisions of the directive, CE marking, otherwise the product is difficult to enter the EU market. As China's propaganda is not enough in this regard, although the three instructions in the AIMD has been enforced for many years, MDD also on June 14 last year to enforce, but there are still many medical device manufacturers and exporters of these requirements are not very understanding, so this year, China's medical equipment exports will face a severe test. This article first describes these three commands in the widest application of the MDD, CE mark and the current application should pay attention to some of the issues for a more detailed explanation for the relevant reference.
a. Medical Devices Directive, MDD
MDD can be seen in Europe is the most comprehensive medical device provisions in the directive, a total of 23 articles and 12 appendices. The important part included in the following terms:
Article 1: This instruction applies to medical devices and their accessories
Clause 2: Member States must ensure that the launch of its market and use of medical devices are safe.
Clause 3: The so-called "security" equipment should meet the basic requirements of Appendix 1.
Article 4: medical devices bearing the CE marking can flow freely in the EU. Special Terms (Appendix Ⅷ and X) allows the use of non-CE marked products and customized clinical research products.
Article 5: compliance with harmonized standards for medical devices is considered to meet the basic requirements.
Article 8: If a device found unsafe, this provision allows Member States to take action.
Article 9: conformity assessment procedures based on product type, classification rules set out in Appendix Ⅸ.
Article 11: medical devices must go through certain procedures (procedures Ⅱ - Ⅶ described) to prove that they meet basic requirements.
17 Terms: meet the basic requirements and has passed the appropriate conformity assessment procedures for medical devices must be marked with CE.
Medical Devices Directive requirements can be summarized as follows:
① All medical devices should meet the basic requirements.
② Each medical devices in the market before, should be adopted in line with evaluation procedures.
③ All the appropriate conformity assessment of medical devices should be CE marked.
Meet these requirements is the responsibility of the manufacturer. Here the so-called "manufacturer" refers to medical devices to market their own name of the person, regardless of whether he actually produced by someone else on behalf of its production or sale of the equipment only, the definition of manufacturer selling only to those who had without the production of the company is facing a new situation. According to instructions, and now they, as manufacturers must meet the applicable provisions of Directive all their obligations.
a. 1 Classification
Medical devices range from plaster to the heart-lung machine, is very broad, very difficult to have a uniform rule applicable to all medical devices. Therefore, the use of a medical device classification system command. It is divided into four categories of medical devices. That is, Ⅰ, Ⅱ a, Ⅱ b and Ⅲ. Class I products also include sterile or measuring functions with the exception of medical devices in general use I * said.
Classification is based on the traumatic, the use of time, use the site and the availability of energy and other criteria. In the Medical Devices Directive Annex Ⅸ total of eighteen classification rules can be used as a device for guidance. The system has the advantage of its "flexibility." For new or little-used medical devices are also able to confirm its type, seemingly without a complete list, but do require frequent modification of medical devices classified directory.
In order to accurately classify medical device manufacturer must determine the intended use of their products. Expected if the product has several uses, the classification must be one of the highest class. For example, for the skin or the heart on the heart suture line is based on the use to classify.
a. 2 special procedures
For both types of medical equipment, that is used for clinical research and medical device customers with special customized program. Without CE mark. This appendix Ⅷ Medical Devices Directive and Appendix X, described in more detail.
a. 3 conformity assessment procedures
Specified in the CE directives for the accreditation process, "conformity assessment procedures." MDD conformity assessment procedures are as follows, according to the classification of the product may be different ways to prove product meets the basic requirements. Manufacturer can choose the program best suited to their requirements.
Appendix Ⅶ MDD conformity assessment procedures can be carried out by the manufacturers themselves, and notice all the other institutions must be involved in conformity assessment procedures.
In Appendix Ⅱ 3, V and Ⅵ in conformity assessment procedures described corresponds to a quality system, but also related to a product. In Appendix Ⅱ 4, Ⅲ and Ⅳ in the program is solely for the purpose described in the product.
Notice mechanical system - depending on the quality of conformity assessment procedures to assess the manufacturer's quality system. This is to audit the manufacturer's production plant, if the majority of production at the supplier's production plant, it also audit the supplier's production plant. Assessment is usually based on ISO9001/2/3 and EN46001 / 2 for, but also under the MDD in some special requirements. According to Appendix Ⅱ, the system must ensure that the production equipment meet the "basic requirements." According to Appendix Ⅴ must ensure that the production of equipment and sample. According to appendix Ⅵ, system must ensure that the necessary final inspection.
a. 4 basic requirements for Medical Devices Directive
MDD described in Appendix Ⅰ The basic requirements include information on the overall design and structure requirements. According to intended use, the product must meet the basic requirements applicable to them. This must be proved by appropriate tests. Products to meet the basic requirements, that is, to meet the directive requirements. Meet the requirements of the most convenient way is to use by the European Committee for Standardization (CEN) Technical Standards Committee and the European Electrical (CENELEC) to develop a harmonized standard. CEN and CENELEC standards are mostly developed with reference to international standards.