Accreditation
If you require European quality systems certification in a regulated industry (e.g. medical, in-vitro diagnostic, etc.) for CE Marking, it may not be sufficient to select a registrar claiming to be "a notified body." For example, there are over 40 registrars/Notified Bodies for the European Medical Devices Directive. However, less than half are notified for an Annex III Type Examination for an active medical device. Also, a Notified Body for one EU Directive is not necessarily notified for other related directives. Less than a quarter of the Notified Bodies for the MDD are also notified for the IVD Directive.
TÜV Rheinland Product Safety GmbH is a Notified Body accredited by the ZLG/ZLS for all three medical directives, namely: AIMD, MDD and IVDD. It is one of the few that are able to offer all the following required services:

• Product testing
  
• Quality management system assessment
  
• Type examination certificate issue
  
• Technical file and design dossier evaluation
  
• Surveillance of product and quality management system
• Identification of standards
  

Laboratories
Our own safety test laboratories are well equipped to test various kinds of medical devices for compliance with national and international standards.