The aim of the guidelines is to promote a common approach by
• manufacturers and notified bodies involved in the conformity assessment procedures
   according to the relevant annexes of the Directives.
• competent authorities charged with safeguarding public health.

MEDDEV guidelines have been carefully drafted through a consultation process with a number of interested parties during which intermediate drafts were circulated and comments were taken up in the documents. Therefore, they reflect positions taken, by representatives of competent authorities and commission services, notified bodies, industry and other interested parties in the medical devices sector.

MEDDEV guidelines are not legally binding. It is recognised that under given circumstances, e.g. as a result of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements. The guidelines can be viewed on http://ec.europa.eu/enterprise/medical_devices/meddev/index.htm