Guidelines relating to medical devices Directives
The guidelines aim at promoting a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the Directives, and by the Competent Authorities charged with safeguarding Public Health
They reflect positions taken in particular by representatives of Competent Authorities and Commission Services, Notified Bodies, industry and other interested parties in the medical devices sector.
The guidelines are not legally binding. It is recognised that under given circumstances, for example, as a result of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements.
Commission guidelines reltating to medical devices Directives:
- Scope, field of application, definition
- Essential requirements
- Classification of MD
- Conformity assessment procedure
- Clinical investigation, clinical evaluation
- Notified bodies
- Products using materials of biological origin
- Market surveillance
- Transitional period
- IVD
Commision Guidance Notes, Interpretative Documents
Commission websites:
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