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EU Medical Device Regulation 2017/745 versus US Food and Drug Administration approval of dermal filler products

EU Medical Device Regulation 2017/745 versus US Food and Drug Administration approval of dermal... Regulations to which dermal filler manufacturers must adhere so as to bring a product to market vary across the world. It is recognised that standards of the EU Medical Device Directive were inadequate, and, as a result of this, it is due to be replaced by the EU Medical Device Regulation (MDR) (EU 2017/745) on 26 May 2021. The EU CE mark will continue to be recognised in the UK until 30 June 2023. Typically, the more rigorous US Food and Drug Administration (FDA) process has been more trusted, but will this still be the case when the MDR comes into force? This piece contrasts and compares the new EU MDR and FDA regulation from an injector perspective. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Aesthetic Nursing Mark Allen Group

EU Medical Device Regulation 2017/745 versus US Food and Drug Administration approval of dermal filler products

Journal of Aesthetic Nursing , Volume 9 (8): 5 – Oct 2, 2020

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Publisher
Mark Allen Group
Copyright
Copyright © 2020 MA Healthcare Limited
ISSN
2050-3717
eISSN
2052-2878
DOI
10.12968/joan.2020.9.8.320
Publisher site
See Article on Publisher Site

Abstract

Regulations to which dermal filler manufacturers must adhere so as to bring a product to market vary across the world. It is recognised that standards of the EU Medical Device Directive were inadequate, and, as a result of this, it is due to be replaced by the EU Medical Device Regulation (MDR) (EU 2017/745) on 26 May 2021. The EU CE mark will continue to be recognised in the UK until 30 June 2023. Typically, the more rigorous US Food and Drug Administration (FDA) process has been more trusted, but will this still be the case when the MDR comes into force? This piece contrasts and compares the new EU MDR and FDA regulation from an injector perspective.

Journal

Journal of Aesthetic NursingMark Allen Group

Published: Oct 2, 2020

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