News from the BioCity Campus

Online Event: Consensus building on product group specific PMCF endpoints for MDR purposes

The AIQNET consortium, together with the industry associations SPECTARIS and BVMed, as well as the Johner Institute am September 27, 2021 developed by 14: 30 16 to: 00 pm to the online eventConsensus building on product group specific PMCF endpoints for MDR purposes" a.

The aim of the event is to initiate a manufacturer-independent process to define product group-specific study endpoints with the participation of the notified bodies, medical device manufacturers and science. Through your participation as an experienced regulatory affairs manager, auditor of a notified body or investigator, you will have the opportunity to actively shape the state of the art with regard to suitable study endpoints for assessing the performance and safety of medical devices. By creating product groups and uniform study protocols, the collection of the required data in clinical practice should be standardized and prospectively possible across manufacturers.

Due to the sharp increase in the need for product-specific clinical data as a result of the MDR, the pressure on hospitals to support manufacturers in generating the necessary data is indirectly increasing. An exclusively prospective survey with individual study protocols can hardly be implemented in everyday life for the required amount of clinical data and runs counter to the primary care mandate of the hospitals. This is where AIQNET comes in, because the aim of the federally funded project is to significantly reduce the effort involved in acquiring and analyzing clinical and medical data in the context of the MDR using a digital ecosystem. The consortium has set itself the task of reaching a consensus on the data to be collected and thus supporting clinics, manufacturers and notified bodies.


14:30 - 14:40  Welcome and presentation of AIQNET by the consortium management (Frank Trautwein, RAYLYTIC GmbH)

14:40 - 14:50  Regulatory framework, requirements of MDR 2017/745 (Johner Institut GmbH, requested)

14:50 - 14:55 Problem of data procurement on the part of the manufacturer (Dr. Andreas Halbleib, Aesculap AG)

14:55 - 15:00 Challenges of data provision by the clinics to support the manufacturers (Prof. Dr. Andreas Nüssler, UKT/BG-Klinik Tübingen)

15:00 - 15:05 Advantages for the notified bodies through consensus building (Martin Tettke, BerlinCert GmbH)

15:05 - 15:15 Presentation of the preparatory work, survey results and considerations on the formation of product groups

15:15 - 15:30 Discussion with the participants

15:30 - 16:00 Definition of the working groups, organizational matters, next steps and farewell (Cordelia Gertz, RAYLYTIC GmbH)

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About AIQNET: AIQNET is a digital ecosystem that enables the use of medical data across sectors and in compliance with data protection regulations. The overall project is being coordinated by BioRegio STERN Management GmbH, Stuttgart. The initiator and consortium leader is RAYLYTIC GmbH based in Leipzig. The consortium of 16 funded and over 50 associated companies in medical technology and healthcare won the federal government’s AI competition in 2019 under the project acronym “KIKS”. Since January 2020, the partners in the BMWi-funded project have been developing the technical infrastructure and applications based on it. The focus is on structuring data with the help of artificial intelligence and creating a legally secure framework for the transfer and use of clinical data. In the future, for example, the performance and safety of medical devices can be measured objectively and largely automatically. Administrative tasks in health care, such as documentation and patient surveys, can be dealt with using appropriate applications. A special feature of the project is the close cooperation between industry, research and supply. Through access to technical and medical data with great depth and a variety of basic services, the ecosystem offers partners the opportunity to develop their own health applications with little effort and to benefit from the legally secure, validated framework of AIQNET.

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