Medical Device Regulation (MDR)
The "European Medical Device Regulation" (MDR) standardizes the requirements for medical devices throughout the EU and also controls the development and assessment processes of system development/modification in the clinical area.
In order to be able to map these requirements uniformly and to support the stakeholder in the assessment, our SAP i.s.h.med colleagues have developed an MDR tool together with Cerner and RnBconsulting. This tool accompanies the development process, starting with the initial assessment through to re-evaluation in the event of a change.
"The EU-regulation affects every clinical organization, regardless of the KIS-System."
Peter Altreiter, Geschäftsführer INFORMATICS Healthcare
Basis of the MDR
The MDR basically controls the following topics:
- When is a software classified as a medical device
- Which roles exist in the process involved
- Which obligations must be fulfilled by the individual roles
- How the development must be carried out and must be documented
Functionality of the INFORMATICS MDR
The MDR tool is a software integrated in SAP i.s.h.med that significantly simplifies the process of MDR compliant software development and classification. The mobile tool guides the user through a questionnaire by means of a Fiori interface. This questionnaire provides for data storage and uniform classification , based on EU legal principles.
The advantages of the MDR Tool
- Security regarding legally compliant classification according to MDR
- Successive expansion of legally compliant customer developments
- Integrated medical device inventory (inventory)
- Transparency in classification and the resulting obligations
- Complete integration into SAP and the processes of the specialist department
- Ongoing expansion of the explanations for the classifications
Expert advice by RnB Consulting, specialist for legal issues in the field of medical software
Technical process support by INFORMATICS, SAP Gold Partner and expert in SAP i.s.h.med.
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