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Comparison of the international regulations for medical devices–USA versus Europe

  • Published:2023-10 Issue: Volume:54 Page:110908
  • ISSN:0020-1383
  • Container-title:Injury
  • language:en
  • Short-container-title:Injury

Author:

Fink Matthias,Akra Bassil

Funder

Osteosynthesis and Trauma Care Foundation

Publisher

Elsevier BV

Subject

Orthopedics and Sports Medicine,Emergency Medicine

Reference18 articles.

1. REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745.

2. COUNCIL DIRECTIVE 93/42/EEC https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31993L0042&from=EN.

3. COUNCIL DIRECTIVE 90/385 /EEC https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31990L0385&from=EN.

4. 21 U.S. Code Chapter 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT https://uscode.house.gov/view.xhtml?path=/prelim@title21/chapter9&edition=prelim.

5. Ongoing problems with metal-on-metal hip implants;Heneghan;BMJ,2012
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