Skip to Main content Skip to Navigation
Master Thesis

Évolution du cadre réglementaire des organismes de certification dans le domaine des dispositifs médicaux

Abstract : Making medical devices available on the market requires, for the various actors concerned, to comply with their own regulatory framework according to their level of responsibility. In Europe, the major players in this sector are the European Commission and the MDCG, with the competent national authorities, then the conformity assessment bodies including notified bodies and certification bodies, accreditation bodies, as well as the various economic operators potentially involved such as manufacturers, authorised representatives, importers and distributors. Changes affecting bodies notified to be designated, certification bodies with the updating of requirements related to their accreditation, as well as developments directly impacting economic operators with Regulations (EU)2017/745 and (EU)2017/746, reflect the regulatory dynamism of this sector. The economic context of these health products, with technological developments impacting the design of innovative medical devices, justifies the implementation of regulatory strengthening to guarantee, in the long term, the safety and performance of the heterogeneity of medical devices in free circulation.
Document type :
Master Thesis
Complete list of metadatas

https://dumas.ccsd.cnrs.fr/dumas-03054129
Contributor : Ufr Santé Unicaen <>
Submitted on : Friday, December 11, 2020 - 12:08:52 PM
Last modification on : Friday, January 29, 2021 - 12:54:58 PM

File

CHUBILLEAU-cecile.pdf
Files produced by the author(s)

Identifiers

  • HAL Id : dumas-03054129, version 1

Citation

Cécile Chubilleau. Évolution du cadre réglementaire des organismes de certification dans le domaine des dispositifs médicaux. Sciences pharmaceutiques. 2020. ⟨dumas-03054129⟩

Share

Metrics

Record views

54

Files downloads

16