Since project start, DiaSys has kept its customers up to date with regard to the implementation steps and requirements. It is becoming apparent that the continued incomplete provision of the necessary infrastructure from the authorities as well as the immense bottleneck with the necessary “Notified Bodies” (Supervising authorities) will lead to problems in implementing the IVDR for the majority of all manufacturers.
For this reason, DiaSys has recently submitted a written petition to twelve local politicians to support a postponement of the effective date (May 2022) of the IVDR by at least one year. As the timely and stringent implementation of the remaining infrastructure is predictably at risk, an urgent need for action has emerged to prevent real bottlenecks in diagnostic testing in order to protect patients, public health and the continuity of health care. As part of their general approach to companies and employers in their own constituency, the two state MPs Jörg Denninghoff and Dr. Tanja Machalet paid a visit to the company DiaSys in May 2021. During a two-hour meeting, DiaSys not only introduced the company's business field, but also their concern regarding a moratorium on the IVDR. Mr. Denninghoff and Dr. Machalet are very interested in the topic and understand the resulting precarious situation for DiaSys as an IVD manufacturer. They left with the promise to pass on the matter to the relevant bodies.
J. Denninghoff, Dr. Machalet as well as DiaSys staff: Dr. Günther Gorka (C.E.O.), Dr. Jan Gorka (C.E.O.), Melanie Schönbach (Works council), Stefanie Giesener (Head of Regulatory Affairs and Quality Management), Stefan Gehm (Head of Production), Ulrich Sander (Head Accounting), Alexander Schwarz Head of IT) during visit at DiaSys on May 17, 2021
Stefanie Giesener