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Editorial
. 2022 Jul 12;1(5):100401.
doi: 10.1016/j.jscai.2022.100401. eCollection 2022 Sep-Oct.

The Impact of the Medical Device Directive to Medical Device Regulation Transition on Early Clinical Testing of Cardiovascular Devices

Adam J Prince  1 , Emily P Zeitler  1 , Aaron V Kaplan  1
Affiliations
Editorial

The Impact of the Medical Device Directive to Medical Device Regulation Transition on Early Clinical Testing of Cardiovascular Devices

Adam J Prince et al. J Soc Cardiovasc Angiogr Interv. .
No abstract available

Keywords: CE mark; medical device; medical device directive; medical device regulatory policy.

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Conflict of interest statement

Dr Kaplan is a Founder and Director of Conformal Medical, Inc, a venture-backed company developing next generation left atrial appendage closure technology. Dr Kaplan reports research support from Boston Scientific and the 3D Symposium support from Abiomed, Abbott Vascular, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Zeitler reports consulting services for Medtronic Inc, Biosense Webster, Boston Scientific, and Sanofi; research support from Boston Scientific and Biosense Webster; and travel support from Medtronic. Dr Prince has no conflicts of interest to report.

References

    1. European Medical Devices Regulation (EU 2017/74). Accessed July 12, 2022. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
    1. European Medical Devices Directive (93/42/EEC). Accessed July 12, 2022. https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042...
    1. Greco C. The Poly Implant Prothèse breast prostheses scandal: embodied risk and social suffering. Soc Sci Med. 2015;147:150–157. doi: 10.1016/j.socscimed.2015.10.068. - DOI - PubMed
    1. Reuters. Staff. Timeline: A short history of breast implants. Reuters Jan 26, 2012. https://www.reuters.com/article/us-france-implants-pip/timeline-a-short-...
    1. Scientific Committee on Emerging and Newly Identified Health Risks. The Safety of Metal-On-Metal Joint Replacements with a Particular Focus on Hip Implants. Adopted this Opinion at the 7th plenary of 24-25 September; 2014. Accessed July 12, 2022. https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_...

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