Orphan Medical Devices in the European Union
Regulatory Q&As for Researchers
The OrphaDev4Kids Project offers regulatory support to stakeholders developing Orphan Medical Devices. We have compiled a series of Regulatory Q&As to help you in your medical device research and development.
In this section you can find the Abbreviations.
.If you need any additional information don’t hesitate to reach out to [email protected]
Artificial Intelligence – AI
European Commission – EC
Clinical evaluation plan – CEP
Clinical evaluation report – CER
European Medicines Agency – EMA
European Union – EU
General Safety and Performance Requirements – GSPRs
Medical Device Coordination Group – MDCG
Performance Evaluation Report – PER
Post- Market Performance Follow-up – PMPF
Periodic Safety Update Reports – PSUR
Post-market clinical follow-up – PMCF
Post-Market Performance Follow-up – PMPF
Post-Market Surveillance – PMS
Regulation (EU) 2017/745 on Medical Devices – MDR
Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices – IVDR