NLMedicalDevices object

Applicable national regulations

Transposition of Directive 90/385/EEC
Transposition of Directive 93/42/EEC
Transposition of Directive 98/79/EC
Transposition of Directive 2007/47/EC
Other

Act on Medical Devices (or comparable national legal framework)

Medical Device Act (Medizinproduktegesetz MPG) - also available in English (non-official translation)
MPG is the transposition of the European Directives into German law.

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

(1) Verordnung über die Erfassung, Bewertung und Abwehr von Risiken bei Medizinprodukten (Medizinprodukte-Sicherheitsplanverordnung - MPSV) / Ordinance on Medical Device Vigilance

(2) Verordnung über klinische Prüfungen von Medizinprodukten (MPKPV)/ Ordinance on Clinical Investigations with Medical Devices

(3) DIMDI-Verordnung (DIMDIV)/ Ordinance for the trial application procedure

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
Feedback