In vitro diagnostic medical device instruction (IVDD) and CE certification
Release date: 2008-01-09
In vitro diagnostic medical devices (IVD) and CE certification have long been a critical part of the European regulatory landscape for healthcare products. The IVDD, or In Vitro Diagnostic Medical Device Directive, was officially adopted by the European Commission on October 5, 1998, and published in the Official Journal of the European Union on December 7, 1998, under number L331. This directive was the last of the three major medical device directives, following the Active Implantable Medical Device Directive (AIMD) and the Medical Device Directive (MDD). Its main goal was to harmonize legal and regulatory requirements across EU member states, ensuring safety and effectiveness for IVD products. The IVDD came into full effect on December 7, 2003, requiring all in vitro diagnostic medical devices entering the EU market to meet its standards and carry the CE mark. The directive consists of 24 articles and 10 annexes, covering areas such as scope, definitions, responsibilities, conformity assessment procedures, technical documentation, labeling, post-market surveillance, and warning systems. The scope of the IVDD includes any reagents, calibration materials, control substances, software, instruments, devices, or systems intended for use in diagnosing or monitoring conditions in vitro. Devices are classified into five risk-based categories: List A, List B, self-testing equipment (excluding blood glucose testing), other products, and performance evaluation equipment. Depending on the classification, manufacturers must choose an appropriate conformity assessment route. Higher-risk devices, like those in List A, require more rigorous evaluations, including design document inspections and batch verification, as outlined in Annex IV. These products must also comply with additional technical specifications to ensure their reliability and safety. For lower-risk IVDs, manufacturers may perform some assessments themselves, but for higher-risk devices, involvement from a notified body is mandatory. Notified bodies evaluate the manufacturer’s quality system, typically based on ISO 13485 standards, along with specific requirements from the IVDD. Once certified, the CE mark can be applied to the product. TUV Rheinland, one of the official notified bodies authorized by the EU (number 0197), plays a key role in supporting companies seeking compliance with EU regulations. With additional accreditations from the FDA and Canadian authorities, TUV Rheinland is also a major member of the CB mutual recognition system. It provides tailored guidance to help Chinese medical device companies successfully navigate the complex regulatory environment and gain access to global markets. Through its expertise, many Chinese firms have expanded their presence in Europe and beyond. ——Shanghai Medical Device Industry Association Network
Spring Safety Vest,Safety Safety,Shirt Hi Vis Jacket
Ningbo Staneex Imp. & Exp. Co., Ltd. , https://www.staneex.com