NLMedicalDevices object

Applicable national regulations

General Act(s) on Medical/Clinical Research in Humans
National Act on Medicinal Products and Medical Devices
Other

Act on Medical Devices (or comparable national legal framework)

1.
Heilmittelgesetz (HMG), Bundesgesetz über Arzneimittel und Medizinprodukte, SR 812.21 (2000)/
Therapeutic Products Act (TPA), Federal Act on Medicinal Products and Medical Devices (NB: en, non-official translation)

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

1. Humanforschungsgesetz (HFG), Bundesgesetz über die Forschung am Menschen, SR 810.30 (2011)
Human Research Act (HRA), Federal Act on Research involving Human Beings (NB: en, non-official translation)
2.
The Federal Council has approved three ordinances on the law on research involving humans, effective as from 01.01.2014:
(1) Verordnung über klinische Versuche (KlinV), Verordnung über klinische Versuche in der Humanforschung, SR 810.305 (2013) / Clinical Trials Ordinance; ClinO (NB: en, non-official translation)
NB: KlinV/ClinO is also applicable to Gene Therapy trials; however, it does not consider clinical trials on vital organs, tissues or ells of human or animal origin including ex-vivo gene therapy!
(2) Organisationsverordnung HFG (OV- HFG); Organisationsverordnung zum Humanforschungsgesetz; SR 810.308 (2013) / HRA Organisation Ordinance (OrgO-HRA) (en, non-official translation)
(3) Humanforschungsverordnung (HFV); SR 810.301 (2013) / Human Research Ordinance (HRO) (NB: en, non-official translation)
3.
Medizinprodukteverordnung MepV

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