Element card for assessment element I0017 in HTA Core Model Application for Diagnostic Technologies (1.1) application

I. Legal aspects

Authorisation & safety

Does the technology fulfil product safety requirements?

Core

The implication of findings in the safety domain should be discussed against the relevant European or national legal frameworks to ensure patient safety from using the technology:

Critical
Complete

Safety aspects

Directive 93/42/EEC, Directive 95/2001/EC