Metec (Germany)

This chapter deals with the specific legal framework, classification, and performance requirements for in vitro diagnostic medical devices (IVDs) under the EU IVD Regulation (EU) 2017/746 and highlights their special role compared to general medical devices, which are subject to the MDR. It outlines the key differences between the assessment approaches—performance evaluation for IVDs versus clinical evaluation for general products—and the implications of the risk-based classification system of the IVD Regulation. The chapter also clarifies when diagnostic software is considered to be IVD software and discusses the strategic importance of early performance evaluation planning. Manufacturers are provided with practical guidance on the conformity assessment and regulatory planning. Furthermore, trends and challenges such as digitalization, AI-based diagnostics, companion diagnostics, and the impact of global regulatory differences are highlighted.

Structures and processes in the atmospheric boundary layer (ABL) span a wide range of scales which cannot be fully captured by a single measuring technique. Doppler lidars are a preferred remote sensing tool for the observation of wind profiles in the entire ABL. Typically the relevant scales of ABL flow structures increase with increasing distance from the surface.While pulsed Doppler lidars (PDLs) are typically sufficiently sensitive to reach the top of the ABL, they leave an unobserved gap in the lowest 50 m. This is because the PDL receiver doesn’t work before the transmit pulse has left the lidar. In addition to the gap, the spatial resolution δr, which is proportional to the pulse length l, is not always satisfying in the lowest range gates, since wind gradients occuring over canopies, urban surface structures or in case of stable stratification cannot be resolved reliably. l cannot be deliberately shortened for the sake of velocity resolution δv and sensitivity s (δv ∝ l-1, s ∝ l).Continuous wave lidars (CDLs) are typically restricted to a maximum height of 200 m. The ranging is here achieved by focusing the beam. With this technique the range resolution δr is not constant but becomes finer the shorter the range r. At r = 10 m, a range resolution δr = few centimeters is possible. Since δr ∝ r2 the resolution at 200 m is no longer superior to that of PDLs. Thus, a CDL is a perfect complement to a PDL in order to observe near-surface structures of the ABL.We will present observations obtained with a PDL-, CDL-combination. Both systems are using an identical scanning cone with a zenith angle of 10°. This scan geometry is particularly suitable for operation close to obstacles as trees or buildings, in urban environments or in complex terrain.

The “Micro Rain Radar” is a vertically pointing Doppler radar operating as a remote sensor for drop size distributions. A concept is proposed to use this technique to support quantitative precipitation retrieval by weather radar.

During 2015-2016, a European Consortium of 15 partners from 8 different countries, developed the DEMETRA (DEMonstrator of EGNSS services based on Time Reference Architecture), a project funded by the European Union in the frame of the Horizon 2020 program. This project aims at developing and experimenting time dissemination services dedicated to specific users like traffic control, energy distribution, finance, telecommunication, and scientific institutions. Nine services have been developed. These services provide time dissemination with accuracy levels from millisecond to the sub-ns, and also additional services like certification, calibration, or integrity. Five of these services are based on the European GNSS. After a development phase (see PTTI 2016 presentation) the full DEMETRA system has been working during six months for demonstration. The paper will report about the experimentation results, showing performances and limits of the proposed time dissemination services, aiming to foster the exploitation of the European GNSS for timing applications.

The atmospheric boundary layer plays an important role in air pollution and dispersion problems because the transport processes are managed within this layer and its top limits the vertical exchange of pollutants. A method for the derivation of the mixing height from measurements of sodar, RASS and sonic anemometer-thermometer is presented for flat terrain. It does not only use vertical profiles of measured parameters but also bulk information like histograms and time evolution. Results from a two-years period are verified by radiosonde-derived mixing height values and show the potential of the combination of the three systems to monitor the mixing height. Difficulties arise at locations in mountainous terrain where thermal wind regimes dominate which are highly non-local. An additional problem is a strong local heat source at an industrial site where even the definition of the mixing height is unclear.