Guidance notes

The free guidance documents below are available for immediate download.

What is ISO 13485:2003? - This guidance document explains in simple, easy to understand terms, the fundamental points of ISO 13485:2003.
Practical Guide to Understanding ISO 13485:2003 - BSI has developed this guidance document in order for you to have a basic knowledge of the details within the ISO 13485:2003 standard.
Medical Device Guidance (MEDDEV's) - Official guidance documents produced by the European Commission
Medical Device Notified Body Recommendations (NB-Med's) - Recommendations on the Directives from the European Notified Bodies Medical Devices Group
Consensus Statements - Agreed interpretations from the European Notified Bodies Medical Devices Group
Other Helpful Documents - A collection of other documents that are of interest to medical devices manufacturers

Kitemark or CE marking for
Medical Devices.

Select the relevant country for your medical device testing requirements: