CE


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EU CE Introduction

CE is a mandatory requirement of the EU. All products sold in the EU market must be labeled with "CE". Of course, it is no exception for the special appliance of medical equipment used as life-saving medical devices. In Europe, in addition to the fact that competent authorities such as industry and commerce inspectors will check whether medical devices on the market carry the CE mark, customs will only allow products with the CE mark to pass through the border. In addition, users of medical devices (doctors, hospitals) will also check for the CE mark when purchasing new devices. Obviously, the CE mark can be used as a "pass" for the appliance within the EU. At the same time, if a medical device product is legally affixed with the CE mark, it also indicates that:

1、The medical device meets the basic requirements of the EU medical device regulations;

2、The medical device can be freely circulated, sold and used in the EU market;

3、The entire formation process of the medical device has passed a corresponding conformity evaluation procedure.

Three EU medical device directives:

In the field of medical devices, the European commission has drawn up three EU directives to harmonise the rules on the launch of such products, in place of the previous member recognition system.

The three instructions are:

1.  AIMDD (90/385/EEC), which is applicable to cardiac pacemakers, implantable insulin pumps and other active implantable medical devices. AIMDD took effect on 1 January 1993.The transitional deadline was 31 December 1994 and was imposed on 1 January 1995.

2.   In vitro diagnostic device directive (IVDD, 98/79/EC), applicable to tumor diagnostic reagents, glucose meters, pregnancy detection devices and other medical devices for in vitro diagnosis.

3.   Medical device directive (MDD 93/42 / EEC), the most widely applicable scope, including the active implantable medical devices and in vitro diagnostic devices almost all outside of medical equipment products, such as medical passive instruments (wound dressings, disposable sterile syringes, corneal contact lens, bags, medical catheter, etc.), active medical equipment (such as magnetic resonance imaging (MRI) nuclear magnetic resonance (NMR) tester, ultrasonic diagnostic instrument, infusion pumps, X-ray machine, electronic sphygmomanometer, etc.) and implantable medical devices (bone plate, screw, joint prosthesis, etc.).The directive entered into force on 1 January 1995, with a transitional deadline of 13 June 1998 and implementation beginning on 14 June 1998.

According to the directive, only medical devices with the CE mark can be sold in the EU market after the implementation of the directive.


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ISC has mature professional technical team, at home and abroad and the strategic cooperation with institutions depth, in the service of medical equipment enterprises, provide enterprises with high quality customized service, to assist enterprises from the product technical requirements, product testing, clinical evaluation and audit, reporting and tracking, according to the enterprise actual situation, to established quality management system, help enterprise from the management to the product each link one-stop service!