Impact of Medical Device Regulation on use of ultrasound-based prediction models in clinical practice

Ultrasound Obstet Gynecol. 2024 May 3. doi: 10.1002/uog.27675. Online ahead of print.

A Kotlarz¹, W Froyman^{2

3}, L Valentin^{4

5}, A Testa^{6

7}, M Van Hove⁸, B Van Calster^{2

9

10}, T Bourne^{2

3

11}, D Timmerman^{2

3}

¹ Department of Gynecology and Oncology, Faculty of Medicine, Jagiellonian University Medical College, Krakow, Poland.
² Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
³ Department of Obstetrics and Gynecology, University Hospitals Leuven, Leuven, Belgium.
⁴ Department of Obstetrics and Gynecology, Skåne University Hospital, Malmö, Sweden.
⁵ Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden.
⁶ Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
⁷ Department of Life Science and Public Health, Catholic University of Sacred Heart Largo Agostino Gemelli, Rome, Italy.
⁸ Legal counsel, UZ Leuven, Leuven, Belgium.
⁹ Department of Biomedical Data Sciences, Leiden University Medical Centre (LUMC), Leiden, The Netherlands.
¹⁰ Leuven Unit for Health Technology Assessment Research (LUHTAR), KU Leuven, Leuven, Belgium.
¹¹ Queen Charlotte's and Chelsea Hospital, Imperial College, London, UK.

No abstract available