Medical examinations often involve calling upon medical laboratory services. Nearly two-thirds of all clinical diagnoses are based to a significant extent on laboratory tests. First of all a sample (e.g. blood) is taken from the patient. This is typically sent to a clinical laboratory in the hospital or to a large external laboratory. The relevant parameters are generally determined with the aid of stationary analysis devices. In recent years great progress has been made in the analysis methods, sensors, signal processing and sample evaluation, but there has also been a significant improvement in the performance of mobile devices. Both factors have resulted in miniaturized mobile diagnostic systems which permit patient-oriented in vitro diagnosis (IVD) outside the conventional central laboratory and require no special infrastructure for their operation.
These advantages have led to a steady increase in the importance of mobile diagnosis systems. There are significant technological, economic and regulatory challenges involved in marketing such systems successfully. Other future tasks include developing robust systems which are suitable for daily use, as well as integrating these into existing technical, informational and organizational environments and procedures.
The legal requirements for mobile diagnostic systems are defined in Germany on the basis of the relevant European directives and national legal and sub-statutory regulations. European legislation is currently being reformed, which is making additional demands on everyone involved.
Mobile diagnosis systems in the form of in vitro diagnostic medical devices can meet the basic requirements of European legislation through the application of harmonized standards. A large number of standards already exist which provide important assistance to the manufacturers of mobile diagnostic systems and their operators.
However, there are gaps in the standards because of the peculiarities of individual mobile diagnostic systems and as the result of technological progress.
The purpose of the first German Mobile Diagnostic Systems Standardization Roadmap is therefore to provide assistance for the development, manufacture and application of mobile diagnostics systems. This includes:
- Development and validation of analytical methods
- Consideration of regulatory requirements during development
- Qualification of supplied parts
- Quality assurance of measurements
- Data security, collection and control
- Training and skills of users in a professional environment and
- Maintenance and repair of mobile diagnostic systems
Also, the reform of EU legislation requires the development or adaptation of normative documents on practical implementation.