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?

Status

Core

Common clarification

Technology specific clarification

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:

Common information sources

Technology specific methodology

Importance

Critical

Transferability

Complete

Common content relations

Technology specific content relations

Safety aspects

Common sequential relations

Technology specific sequential relations

Common reference

Technology specific reference

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

HTA Core Model® Online

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?

HTA Core Model^® Online