NLMedicalDevices object

Applicable national regulations

National Act on Medicinal Products and Medical Devices
Transposition of EU Directives on MD
Other

Act on Medical Devices (or comparable national legal framework)

(1) Law 29/2006 on Medicinal Products and MD
(2) Royal Decree 1090/2015
(2) Royal Decree 1591/2009, on Medical Devices (Real Decreto 1591/2009, de 16 de octubre, por el que se regulan los productos sanitarios)
(3) Royal Decree 1616/2009 on Active Implantable Medical Devices

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

(1) Royal Decree 1090/2015

(2) Circular 7/2004 on Clinical Investigations with MD (Circular Nº 07 / 2004, investigaciones clínicas con productos sanitarios) incorporates Royal Decree 223/2204 and other applicable regulations.

3) Registry: Ordinance SCO/3603/2003 (Orden SCO/3603/2003, de 18 de diciembre) regulates Registries of active implantable medical devices

Additional Information

Observational studies:
Orden SAS/3470/2009, de 16 de diciembre, covers postauthorization (observational) studies with MP for human use.

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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