Release date: 2008-01-09
In vitro diagnostic medical device instruction (IVDD) and CE certification
The European Commission officially adopted the 98/79/EC In Vitro Diagnostic Medical Device Directive (hereinafter referred to as the IVDD Directive) on October 5, 1998, and was first announced on the European Union Gazette No. L331 issued on December 7, 1998. The IVDD directive is the last of the three medical device directives in the European Union. The purpose of the Active Implantable Medical Device Directive (AIMD, 90/335/EEC), Medical Device Directive (MDD, 93/42/EEC) is the same, and the IVDD Directive is also intended to coordinate the legal and regulatory requirements of each Member State.
From December 7, 2003, the IVDD directive began to be enforced. All in vitro diagnostic medical devices entering the EU market must comply with the requirements of the IVDD directive and bear the CE mark.
The IVDD instruction has 24 terms and 10 appendices. Its contents include: scope of application, definition, responsibility, compliance assessment path, technical documentation requirements, quality system, product labeling, post-marketing supervision system, and the establishment of a warning system in each member state.
IVDD Directive Scope: Any medical device that is a reagent, calibration substance, control substance, software, instrument, device, or system.
The instructions are divided into five categories based on the intended use and risk of the IVD device: List A, List B, self-testing equipment (except blood glucose testing), other products and performance evaluation equipment.
Depending on the product classification, the manufacturer can select a conformity assessment procedure that suits its requirements to demonstrate that its product meets the basic requirements of the IVDD directive (Figure 1). The choice of compliance assessment path is based on the risk of the product, the higher the risk of the product, the more stringent the requirements of the assessment path. For example, because List A's products are extremely risky, according to the requirements of Appendix 4, the evaluation path of such products must include the inspection and batch verification of the design documents (Sections 4 and 6). In addition, the requirements in the instructions The performance evaluation of such products shall also comply with the requirements added to such products in the General Technical Specifications.
The conformity assessment procedures for other in vitro diagnostic medical devices (IVDD Appendix 3) and the in vitro diagnostic procedures for performance evaluation of in vitro diagnostic medical devices (IVDD Appendix 8) may be performed by the manufacturer itself, all other compliance The evaluation process must involve the notified body. The notified body reviews the manufacturer's quality system based on the conformity assessment procedures for the quality system. The review is usually conducted in accordance with ISO 13485 and, of course, the special requirements specified in the IVDD Directive.
Therefore, for higher-risk in vitro diagnostic medical device products, product certification must be performed by a notified body officially authorized by the European Union. Manufacturers can apply for registration to the notified body, and after successful certification, they can officially mark the CE mark on their products.
The TUV Rheinland Group is an officially authorized notified body of the European Union (announcement agency number 0197), which can provide relevant EU directive certification for enterprises and is a reliable partner to help Chinese medical device companies obtain European market passes. In addition, TUV Rheinland also has the authorization of the US FDA and Canadian medical device certification, and is also the main NCB member of the CB mutual recognition system. It can recommend the most suitable evaluation procedures according to the different situations and needs of the company. Chinese companies in the medical device sector have successfully entered the European and global markets. ——Shanghai Medical Device Industry Association Network
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