Guide to the Classification of a Medical Device
27 April 2009
This guide relates to the classification of general medical devices and the application of the classification rules and related guidance. It does not apply to active implantable medical devices or in-vitro diagnostic medical devices. It sets out, inter alia, the reasons for classification and the method by which classification can be determined.
Click on the link below to open the guide:
Guide to the Classification of a Medical Device
Click on the link below to open the application form to submit a request for classification of a medical device:
Request for Classication of a Medical Device