Full text of EU MDR (Medical Device Regulation)
[simple-social-share css="0"]
EU MDR Chapter 4 Article 43

Article 43 – Identification number and list of notified bodies

  1. The Commission shall assign an identification number to each notified body for which the notification becomes valid in accordance with Article 42(11). It shall assign a single identification number even when the body is notified under several Union acts. If they are successfully designated in accordance with this Regulation, bodies notified pursuant to Directives 90/385/EEC and 93/42/EEC shall retain the identification number assigned to them pursuant to those Directives.
  2. The Commission shall make the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the conformity assessment activities as defined in this Regulation and the types of devices for which they have been notified, accessible to the public in NANDO. It shall also make this list available on the electronic system referred to in Article 57. The Commission shall ensure that the list is kept up to date.
IMPLEMENT ISO 13485 & MDR
BY YOURSELF

SEE HOW IT WORKS

  • Optimized for small and medium-sized companies
  • Costs up to 80% less than using consultants
  • Expert consultations and unlimited email support available
  • Created by Advisera, the leading website for compliance