This initiative is a collaboration with the following associations:
- OSMI (Overview Software MDR & IVDR)
- BMTZ (Beroepsvereniging voor Biomedisch Technologen)
- NVKI (Nederlandse Vereniging voor Klinisch Informatica)
To implement the MDR and IVDR, the European database Eudamed
is currently being developed, which can be consulted by suppliers and healthcare institutions. Since Eudamed is not yet ready, but the need for information already exists due to the upcoming deadline, there is now the OSMI (Overview Software MDR & IVDR) initiative from BMTZ and NVKI. Healthcare institutions can gain direct insight into the MDR & IVDR status of (medical) software by means of the OSMI database.
OSMI will consist of an online, public platform with an overview of (medical) software used in healthcare institutions. The OSMI database will include information about the CE certificate (issued under the MDD, MDR, IVDD or IVDR). The platform is hosted and managed by BMTZ and NVKI. It's important for the continuity and safety of care, for Dutch hospitals to obtain a clear insight into the status of (medical) software.
For addition questions, please contact us by the Contact form
This list is a temporary generated medical software database, supported until the international Eudamed database will be launched.
The goal of this medical software list is to reduce the risk of suppliers not
meeting the legal MDR & IVDR requirements.
- This list will also prevent hospitals individually contacting the medical software suppliers, asking for the same MDR & IVDR documents such as the CE-certificate.
- The listed medical software is not traceable to hospitals.
- Suppliers contact information will not be visible for visitors.
Product information and classification
The product information in this Medical software database is added by suppliers and hospitals.
OSMI is not responsible for the outcome of these information. If you have questions
regarding information or documents in this list, we advise you to contact the software supplier.
The listed medical software is not traceable to hospitals. For more information about the data
privacy, we advise you to look at the privacy statement of NVKI.