Element card for assessment element I0030 in HTA Core Model Application for Diagnostic Technologies (1.1) application

I. Legal aspects

End-user

Who is the intended end-user of the technology?

Status

Core

Common clarification

Technology specific clarification

Different requirements may apply depending on the answer. E.g. consumer Information, CE-marks, easiness of use, exactness of the results etc. are to be evaluated differently if the technology is intended to laymen’s use.

Common information sources

Technology specific methodology

"In vitro diag. directive 98/79/EC; " Council of Europe Gen testing protocol 2008

Importance

Critical

Transferability

Complete

Common content relations

Technology specific content relations

Common sequential relations

Technology specific sequential relations

Common reference

Technology specific reference

"Directive 98/79/EC; " Council of Europe Gen testing protocol 2008

HTA Core Model® Online

Element card for assessment element I0030 in HTA Core Model Application for Diagnostic Technologies (1.1) application

I. Legal aspects

End-user

Who is the intended end-user of the technology?

HTA Core Model^® Online