Orphan Medical Devices and Pediatric Cardiology – What Interventionists in Europe Need to Know, and What Needs to be Done

Author:

T Melvin,D Kenny,M Gewillig,AG Fraser

Publisher

Springer Science and Business Media LLC

Subject

Cardiology and Cardiovascular Medicine,Pediatrics, Perinatology and Child Health

Reference36 articles.

1. Sutherell JS, Hirsch R, Beekman RH 3rd (2010) Pediatric interventional cardiology in the United States is dependent on the off-label use of medical devices. Congenit Heart Dis 5:2–7. https://doi.org/10.1111/j.1747-0803.2009.00364.x

2. Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex:31990L0385. Accessed 17 October 2022

3. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042. Accessed 17 October 2022

4. Article 5, Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A31965L0065. Accessed 17 October 2022

5. Cohen D (2012) Faulty hip implant shows up failings of EU regulation. BMJ 23(345):e7163. https://doi.org/10.1136/bmj.e7163

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