Guidelines and Forms

Clinical Investigations of Medical Devices - Forms

Form

Name

Engl. version

Valid. since

Replaces

Amends

Formulář KZ ZP

Clinical Investigation Notification Form  

Annex 16 to to the Governmental Regulation No. 336/2004 Coll.

YES

01.04.2011

-

-

Formulář KZ AIZP

 Clinical Investigation Notification Form

Annex 12 to the Governmental Regulation No. 154/2004 Coll.

YES

01.04.2011

-

-

Tabulka hlášení SAE

SAE Reporting Form

Annex to MEDDEV 2.7/3

YES