The Fall Out of the 2017 European <i>Medical Device Regulation</i> for Tracheal Occlusion
This scenario highlights the unintended consequences of stringent medical device regulations, leading to their unavailability for beneficial procedures or complicated administrative processes, even as these devices remain available outside the EU.
Authors
- Beverley Power (ORCID: https://orcid.org/0000-0002-4224-4826)
- Alexandra Benachi (ORCID: https://orcid.org/0000-0001-6045-0765)
- Frank Meijer (ORCID: https://orcid.org/0000-0003-3210-4405)
- Francesca Maria Russo (ORCID: https://orcid.org/0000-0002-5029-7899)
- Jan A. Deprest (ORCID: https://orcid.org/0000-0002-4920-945X)
- Fanny Cauvet
- Hélène Berrué‐Gaillard
Institutions
- Université Paris-Saclay (FR)
- Neuropsychiatrie : Recherche Epidemiologique et Clinique (FR)
- Queen Elizabeth Hospital King's Lynn NHS Foundation Trust (GB)
- London Women's Clinic (GB)
- Hôpital Antoine-Béclère (FR)
- University College London (GB)
- KU Leuven (BE)
Publication Details
- Journal
- Prenatal Diagnosis
- Published
- 2025-03-15
- DOI
- https://doi.org/10.1002/pd.6763
- Citations
- 2
- Primary Topic
- Congenital Diaphragmatic Hernia Studies
- Type
- article
- Field-Weighted Citation Impact
- 4.01