Essentials of European Medical Device Regulatory Affairs

NB Assessment of Equivalence • Does the demonstration of equivalence cover all models / sizes / variations of the subject devices • Has the manufacturer provided a detailed documentation and discussion of all design differences between their device and the claimed equivalent, including a critical evaluation of the potential impact of any such differences on clinical safety and performance ? • The Assessor has to decide if they agree with the manufacturers conclusions, and confirm that there are no differences of materials or intended use, and no significant design differences • Is the level of access that the manufacturer has to the clinical data considered acceptable • If the equivalent device is not CE-marked, is there a justification for use of the clinical data and is the justification considered satisfactory

The Organisationfor Professionals inRegulatory Affairs

Workshop – Is equivalency demonstrated ?

Review of Results of Equivalence Workshop

The Organisationfor Professionals inRegulatory Affairs