Essentials of European Medical Device Regulatory Affairs

Workshop – Is equivalency demonstrated ?

• Divide into groups • Review information provided • Record conclusions and reasons for your decision • 30 Minutes to complete the exercise

The Organisationfor Professionals inRegulatory Affairs

Device 1

Device is a silver coated wound dressing:  Equivalency has been claimed to the same wound dressing without silver  Silver which is an ancillary medicinal substance is subjected to a consultation with an EU competent authority

Would you accept equivalency ? Please provide a reason for your conclusion

The Organisationfor Professionals inRegulatory Affairs