SAP B1 blog

The legal basis

The EUDAMED database was introduced as part of two key EU regulations:

• EU Regulation 2017/475 on medical devices (MDR)
• EU Regulation 2017/749 on in vitro diagnostic medical devices (IVDR)

These regulations replace the previous directives and introduce new requirements and classification systems for medical devices and medical technology. This is intended to ensure stricter authorisation and monitoring procedures as well as improved traceability.

What is regulated by EUDAMED?

With the introduction of EUDAMED, various aspects of the regulation of medical technology products are changing

New classification systems:

Medical devices and in-vitro diagnostics are classified according to stricter criteria in order to better assess their safety and effectiveness.

Authorisation and monitoring requirements:

The requirements for the authorisation, monitoring and marketing of medical devices and in-vitro diagnostics are increasing.

Traceability:

The introduction of Unique Device Identification (UDI) improves the traceability of products.

Clinical evaluations:

Increased demands are being placed on clinical assessments and the provision of clinical data.

Consumer information:

Patients and consumers should receive more information about the products used.

Obligations of manufacturers and economic operators

For manufacturers, authorised representatives and importers of medical devices and medical technology products, the introduction of EUDAMED results in various obligations:

• Registration in the EUDAMED systemAll economic operators must store their company data in EUDAMED.
• Product registrationInformation such as name, model, classification, place of manufacture and scope of application of the products must be entered. UDI data is also required.
• Updating the dataAll registered information must always be kept up to date, including changes to the product or the conformity assessment.
• Provision of clinical dataClinical data, including information on clinical studies, must be entered in EUDAMED.
• Reporting of incidentsAny incidents involving the products must be documented and reported.

Role of the XML schema in data transmission

The XML schema is set for data transfer to EUDAMED and plays several important roles:

1. Data structuringThe XML schema defines the structure and format of the data that is transmitted to EUDAMED. It specifies which elements and attributes must be contained in the XML files and how they should be arranged.
2. ValidationThe XML schema (XSD) contains rules for validating XML documents. For example, it checks whether certain fields have a specified number of letters or numbers and whether the data is in the correct format.
3. Business rulesThe XML schema integrates specific business rules of the European Commission that must be taken into account when transmitting data.
4. Data exchange formatXML is the format accepted by EUDAMED for data exchange. Manufacturers must convert their product data into this format in order to upload it.
5. Bulk uploadThe XML schema enables the mass upload of data, which is particularly efficient for manufacturers with many products.
6. InteroperabilityThe use of a standardised XML schema ensures interoperability between different systems and EUDAMED.
7. Error minimisationThe use of the XML schema helps to minimise errors during data transfer, as it allows data to be validated against the defined rules before uploading.
8. automationThe XML schema also enables the development of automated processes for data transfer, such as machine-to-machine (M2M) interfaces.

Advantages of EUDAMED

By centralising all relevant data in EUDAMED, national authorities can work more efficiently and check the conformity assessments of products more effectively. This should therefore lead to greater safety for consumers and improved transparency in the market for medical devices and medical technology products.