Essentials of European Medical Device Regulatory Affairs

Device 2

Device is a Titanium alloy screw for orthopaedic use  Equivalency has been claimed to a Cobalt Chromium Ally coated with Titanium nitrate  Both materials meet the relevant standards  Devices have same intended use  Biocompatibility studies performed per ISO 10993 show both devices are safe Would you accept equivalency ? Please provide a reason for your conclusion

The Organisationfor Professionals inRegulatory Affairs

Device 3

Device is a bioresorbable stent (PLLA) intended for use in peripheral vessels  Equivalency has been claimed to another bioresorbable stent made of magnesium, with the following rationale;  Both stents are indicated for the use site and have same intended use  Both stents degrade and nothing is left behind after 12m

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

The Organisationfor Professionals inRegulatory Affairs

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