Element card for assessment element I0015 in HTA Core Model Application for Diagnostic Technologies (1.1) application

I. Legal aspects

Authorisation & safety

Has the technology national/EU level authorisation?

Status

Core

Common clarification

Technology specific clarification

Patient safety as expressed in product safety is one domain of health care technology assessment which clearly falls under the mandate of the European Union

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

HTA Core Model® Online

Element card for assessment element I0015 in HTA Core Model Application for Diagnostic Technologies (1.1) application

I. Legal aspects

Authorisation & safety

Has the technology national/EU level authorisation?

HTA Core Model^® Online