MDStudy object

MD - Definition available in national law

Yes

MD - Definition

Definitions for Medical Devices (intended for clinical investigations) are given in Article 3, DL 145/2009 (pt).
The classification criteria for class I, IIa, IIb, III Medical Devices are provided in Art 4 & Annex IX of DL 145/2009 (pt).

Additional Information

The related definitions and classifications are also available in EN on the INFARMED website in section: Dispositivos Médicos

Feedback