NLMedicalDevices object

Act on Medical Devices (or comparable national legal framework)

(1) Act on Medical Devices, No. 16/2001 as amended by Act No. 76/2002, Act No. 88/2008 and Act No. 28/2011.
This act includes provisions on safety requirements, labelling, instructions for use, treatment, clinical investigation and surveillance with medical devices.
With Icelands participation in the EEA, the three EU directives (90/385/EEC, 93/42/EEC, 98/79/EC) came into effect.
(2) Regulation on Medical Devices No. 934/2010

Other applicable regulations / implementing provisions (Acts, laws, decrees, ordinances, circulars, etc)

(1) Act on Scientific Research in the Health Sector No. 44/2014 („Scientific Research Act 2014“).
It applies to scietific studies carried out, in whole or in part, in Iceland.

(2) Act on Patient Insurance, No. 111/2000, as amended:
Patients who suffer physical or mental damage in connection with examination or medical treatment in a hospital, health-care centre or other health institution are covered by this act.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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