Failure to implement an appropriate PMCF system may result in loss of MDR regulatory approval and CE-marking.
It is therefore essential to ensure that any PMCF system is well-constructed and suitable for its intended purpose. Our expert team offer a complete PMCF advisory and design service dedicated to ensuring compliance with all MDR requirements.
Please note that this may change for your medical device if you:
- modify its intended purpose
- change its risk profile
- alter its indications
- change its target patient population
- are advised otherwise from a regulatory body
* Disclaimer: Outputs from this tool are indicative only and do not constitute formal advice. Mantra Systems Ltd accepts no responsibility for any party's interpretation of, or application of, results of this tool.