A clinical investigation is defined as any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety, clinical performance and/or effectiveness of a medical device.
A clinical investigation is defined as any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety, clinical performance and/or effectiveness of a medical device.
In the European Union class III, active implantable medical devices and some of class IIb medical devices are subject to clinical investigations. In the case of some high-risk devices clinical investigations might be waived but the waiver must be appropriately justified.
In the US almost all class III devices and approximately 10-15% of class II devices, which are not 510(k) exempts, require clinical investigations. Usually, FDA recognizes clinical investigations conducted outside the United States provided that they comply with the international clinical research standards.
In the Latin American countries clinical investigations are required for high-risk products (classes III and IV in Brazil, Argentina and other Mercosur countries, class III in Mexico). Mostly, these regulatory authorities accept clinical investigations conducted in other countries provided that they comply with the international clinical research standards.
In the European Union class III, active implantable medical devices and some of class IIb medical devices are subject to clinical investigations. In the case of some high-risk devices clinical investigations might be waived but the waiver must be appropriately justified.
In the US almost all class III devices and approximately 10-15% of class II devices, which are not 510(k) exempts, require clinical investigations. Usually, FDA recognizes clinical investigations conducted outside the United States provided that they comply with the international clinical research standards.
In the Latin American countries clinical investigations are required for high-risk products (classes III and IV in Brazil, Argentina and other Mercosur countries, class III in Mexico). Mostly, these regulatory authorities accept clinical investigations conducted in other countries provided that they comply with the international clinical research standards.
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