Clinical Evaluation Medical Devices Development


This Standard Operating Procedure (SOP) describes the individual steps and process necessary to comply with the Clinical Evaluation for medical devices. This SOP applies to all Medical Devices under development after concept and feasibility studies are completed.

Demonstration of conformity is requested by the Council Directive 93/42/ECC, Annex I, with the relevant essential requirements, which include a clinical evaluation in accordance with Annex X.