Medical device CE
On October 27, 1998, the European Commission formally adopted the In Vitro Diagnostic Medical Devices Directive (hereinafter referred to as the IVDD Directive) and announced it in EU Communiquy L331 of December 7, 1998. According to the contents of the communique, EU Member States must complete the formulation and announcement of the relevant statutory orders required for the implementation of this Directive by 7 June 2000. Since December 2003, all in Vitro Diagnostic Medical Devices (IVD) sold in EU Member States must comply with this Directive. Only when the conformity evaluation procedure is completed and CE mark is affixed can the company be listed in the EU.
Determine whether the product is IVD
The manufacturer should first determine whether the product is an in vitro diagnostic medical device according to the definition of in vitro diagnostic medical device. According to the definition of EU Directive 98/79/EC on in vitro diagnostic medical device, the definition of in vitro diagnostic medical device refers to any reagent, correction substance, reference substance, instrument, device or system. Therapeutic devices, whether used alone or in combination, are designated by the manufacturer for in vitro testing of human samples, including blood and tissues. Individual or mainly used to provide the following relevant information:
* About physiological or pathological state
* or about congenital anomalies
* Or decide on safety and compatibility with potential transplant recipients
* Or monitor the therapeutic effect.
Sample containers are also considered as in vitro diagnostic medical devices, whether in vacuum or not, designated by the manufacturer to store samples taken from the human body for in vitro diagnostic testing purposes. For example, one-time vacuum blood vessel collection. General laboratory equipment does not belong to in vitro diagnostic medical equipment unless the manufacturer specifically declares that the equipment is in vitro diagnostic medical equipment according to its product characteristics.
The manufacturer can only continue if it determines that its product is IVD, otherwise it has to choose other corresponding methods. At present, some domestic manufacturers encounter difficulties in this respect, such as the production of drug abuse test kits, or athletes doping test kits. According to the definition of IVDD directive, these products are not in vitro diagnostic medical equipment, so they can not apply for CE certification according to IVDD directive.
Determining the Classification of IVD Products and Choosing the Approach of Conformity Evaluation
The manufacturer is confirming that its product is IVD, so the next step is to determine its classification and conformity evaluation path. According to the requirements of IVDD directive, IVD products can be divided into five categories: List A, List B, self-detection materials (except for blood sugar detection), other products and performance evaluation equipment. Each type of conformity evaluation approach (that is, the way to obtain CE certification) is different.
Establishment and maintenance of quality management system
After the manufacturer has determined the way of product classification and conformity evaluation, it is necessary to establish a quality management system according to the requirements of IVDD in order to meet the requirements of IVDD. At present, the quality management system of GMP is generally established in accordance with the requirements of SFDA by the domestic manufacturers of in vitro diagnostic medical equipment. But GMP standard is not the coordination standard of IVDD. The coordination standard of IVDD for quality management system is ISO13485/8:1996 or ISO13485:2003. Therefore, manufacturers should establish quality management according to the requirements of ISO13485. In addition, some special requirements of IVDD are added, such as alert system, self-compliance statement and so on.
For the manufacturers who have established GMP system, the requirements of IVDD are integrated organically on the basis of not breaking the familiar GMP or ISO13485 file structure, so as to establish a unified quality management system of GMP/ISO13485/IVDD, which can meet the needs of auditing by different organizations.
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