Dr. Zeynep Schreitmüller

Dr. Zeynep Schreitmüller specialises in advising on medical device law and drafting contracts in the life science sector. In medical device law, she supports companies in all regulatory issues and in implementing the requirements of the Medical Device Regulation (MDR) and the IVD Regulation (IVDR). One of her specialisation is on topics related to e-health and artificial intelligence (AI). In particular, she focuses on the area of AI-supported medical devices and advises from the development to the application of these products. In this context, she also advises companies on the interface with health data protection, in particular on the requirements of the General Data Protection Regulation (GDPR) in the development of data-driven medical devices as well as on the design of data sharing agreements.

Dr. Zeynep Schreitmüller advises companies on all questions and aspects of medical device law, in particular those arising from the MDR, the IVDR and the MPDG. She focuses on advising on the requirements for software-specific medical devices and their differentiation from "lifestyle apps". She has particular expertise in the regulation of AI-supported medical devices and the special regulatory dynamics consisting of the MDR, the GDPR, and also the AI Act that will apply in the future. She accompanies companies from the product idea to the development and application of intelligent medical devices. In doing so, she focuses her advice on both the data protection requirements for the product itself (Privacy by Design) and the data protection-compliant handling of training and test data, in particular the lawful processing of data in the development stage. Further focal points include advising companies and research institutions on clinical trial law as well as in the areas of human and veterinary medicinal products.

  • legal studies at the University of Augsburg
  • legal clerkship at the Higher Regional Court of Munich with stations at BMW Group, among others
  • research assistant at the Chair of Public Law, International Law and European Law (Prof. Dr. Thilo Rensmann, LL.M.) at the University of Augsburg
  • 2022 doctorate thesis on the topic of “Regulation of Intelligent Medical Devices” (Prof. Dr. Ulrich M. Gassner); awarded wih the Scientific Prize for Medical Device Law 2022 and the Dissertation Prize of the Juristische Gesellschaft e.V. 2023
  • since 2022, legal advisor at the German Patent and Trademark Office (supervision according to the Verwertungsgesellschaftengesetz)
  • since 2023, lawyer at the Produktkanzlei

Languages: German, English, Turkish

  • Cybersicherheit KI-basierter Medizinprodukte im Lichte der MDR und KI-VO (with Henrik Nolte), MPR 2024, p. 20 ff.
  • Geplante PFAS-Beschränkung und MDR – Regulatorische Friktion zu Lasten des Medizinproduktesektors? (with Martin Ahlhaus), MPR 2023, p. 171 ff.
  • Künstliche Intelligenz im Arbeitsschutz – Das künftige EU-Haftungsregime für Anbieter, Nutzer und Wirtschaftsakteure (with Dr. Carsten Schucht), ARP 2023, S. 226 ff.
  • Regulierung intelligenter Medizinprodukte – Eine Analyse unter besonderer Berücksichtigung der MPVO und DSGVO, 2023