OrphaDev4Kids Services and Tools
The OrphaDev4Kids Project aims to provide access to a complex ecosystem including tools, facilities, and supportive services, aimed to maximise the value-for-patients of the research and development of paediatric MDs projects. This will allow to ameliorate the connection between relevant players (e.g. academia, scientific societies, users) with orphan device ideas with potential manufacturers (SMEs and companies), to help developers to identify existing financing resources (considering both grants and private funds) and funds to be addressed, and also to increase their knowledge about the more relevant procedures and disposition to be followed in Europe, at different national levels and in relevant non-European MDs markets.
Main goals
The OrphaDev4Kids Project will provide funding advice, network building, technical advice, regulatory guidance to advance medical device development for orphan and paediatric populations. You can access the service request below.
Furthermore, we also offer a funding and regulatory database to help advance medical device development.
Open Call to support paediatric and orphan medical device development
The OrphaDev4Kids Project aims to grant access to an ecosystem including tools, facilities, and supportive services (e.g. funding advice, network building, technical advice, regulatory guidance) to advance medical device development for orphan and paediatric populations.
OrphaDev4kids invites academics and individual researchers, startups and industrial players, organizations from diverse settings, and patient-led developers, to request for supporting services both for new device development and for the adaptation of existing products for the orphan and paediatric populations.
Successful applicants will benefit from the support of dedicated experts to help achieve their project’s development goals.
To submit a request for supporting services for orphan and paediatric medical device development please fill in the Service Request Form, specifying the services you are interested to, sign it, upload the Confidentiality Disclosure Agreement and submit the request.
Please note that in the Service Request Form we are collecting all the services users might be interested in, but only funding advice, network building, technical advice and regulatory guidance will be provided by OrphaDev4Kids.
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.
Under this section you can find the following topics:
- Applicable Regulatory Framework
- EU Regulatory Context and Definitions
- Clinical Evidence and Investigations
- Derogations and Exceptional Mechanisms
- Strategic Considerations for Researchers
- Glossary
- Abbreviations
If you need any additional information don’t hesitate to reach out to [email protected]