MD/IVD CE Mark
EU Product Registration
Your Trusted EU Compliance Partner
We register your MD/IVD products in EU
Before placing a medical device or in vitro diagnostic device on the market, manufacturers must register or notify the product with the appropriate Competent Authority or through EUDAMED, as required by the applicable regulations.
A Competent Authority is the national regulatory body responsible for overseeing the registration and vigilance of medical devices and in vitro diagnostic devices. As your EU Authorised Representative, Medunion will handle the registration of your MD/IVD products in Spain, where AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) serves as the supervising Competent Authority.
EUDAMED
Established under Regulation (EU) 2017/745 (MDR), it facilitates information exchange between Competent Authorities and the European Commission, supporting transparency and regulatory oversight.
EUDAMED (European Database on Medical Devices) is the central EU database for medical devices placed on the European market. Entities such as manufacturers, authorised representatives, importers, and system or procedure pack producers operating in the EU, as well as in Iceland, Liechtenstein, Turkey, or Northern Ireland, must register in the EUDAMED database. Non-EU manufacturers may only register if their authorised representative is based within one of these regions.
Each eligible entity applies for actor registration and is assigned a unique Single Registration Number (SRN). If an entity performs multiple roles—such as manufacturer and importer—it must register each role separately and will receive a distinct SRN for each.
Ready to bring your MD/IVD to the EU?
Our experienced team is ready to guide you through the regulatory process, ensuring your product meets all applicable requirements with confidence and efficiency.
Avoid unnecessary delays—get in touch with us today and take the next step toward faster, compliant market access.
- Simplifying Regulatory Compliance for Medical Devices Across Europe.
