In the European Union, the fulfillment of EU Directives (e.g., Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices. A significant portion of demonstrating compliance with the EU directive requirements is the establishment and independent assessment of the quality system.

The current European medical device quality system standard is EN ISO 13485:2003, which will replace current harmonised standards EN ISO 13485:2000 and EN ISO 13488:2000 with a three year transition period ending July 2006.

When manufacturers are active in the world market, the focus on global or international standards (e.g., ISO) is not only advantageous – it may be stipulated by certain countries. For example, Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485:2003. TÜV SÜD America is an SCC qualified ISO 13485 Registrar for the Canadian Medical Devices Regulations.

In the US, the revised Quality System Regulation (21 CFR 820, Oct. 7, 1996) was based on the ISO 9001 and ISO 13485 quality system standards. US manufacturers in compliance with the FDA Quality System Regulations can assume that their quality system is close to meeting the requirements of the ISO 9001 or ISO 13485 standards.

ISO 13485 – Who is certified to these standards?

  • Companies who currently manufacture private label medical devices, but want to eventually place these devices under their name on the market in the European Union
  • Companies, such as consulting shops, which design, manufacture, and assemble medical and in vitro diagnostic medical devices, and medical component manufacturers
  • Manufacturers of In Vitro Diagnostic Medical Devices that want to distinguish themselves, and prepare for future IVD regulatory obligations to enter the EU


TÜV SÜD Product Service is accredited by the ZLG in Bonn, Germany, as a Certification Body for quality management systems to ISO 13485. TÜV also holds accreditation with the Standards Council of Canada (SCC) and Health Canada for the Canadian Medical Devices Regulations. In addition, TÜV SÜD a Notified Body for certification to all relevant EU Directives. With this complete service package, TÜV SÜD can assist medical companies in accessing markets nationally, in Europe, and globally.