Overview of relevant standards
Before a medical product is placed on the market, it must fulfil certain standards. These standards are derived from directives that apply in the whole of Europe.
The most different standards must be observed when a medical product is labelled and finally marketed. The requirements are defined in the medical products directive (92/93/EEC) as well as in the appropriate directive for in-vitro diagnostics (98/79/EC). These regulations include the CE conformity marking and, in some cases, an additional assessment by notified bodies.
These international requirements define the scope for concrete standards. The following standards are important for the conformity assessment of medical products:
- standards on the safety and usability (DIN EN 60601, DIN EN 60601-1-6, DIN EN 62366), including specifications on the documentation form, e.g. in a usability file
- standards on risk management (ISO 14971:2007)
- standards on quality management (ISO 9001:2000, ISO 13485:2003)
After it was verified by auditors from UID and consulting & more whether these standards have been met in the development, the medical product is allowed to be placed on the market.
Relevant standards to place on the market at a glanceenlarge image