Medical Device Comm
The testing of the safety and effectiveness of medical devices should be done in a GLP accredited facility, or a facility which adheres to ISO 17025.
Refer to ISO 10993-1 for biocompatibility testing (safety), and for effectiveness (=efficiency/evaluation) refer to MEDDEV 2.7.1, 2.7.2, 2.7.3 and 2.7.4.
Essential Requirement 6a refers to Annex X which provides additional requirements for clinical data, including when a clinical investigation is necessary. See also MEDDEV 2.7.1 for further guidance. If a clinical investigation is required the requirements of ISO 14155-1 should be applied.