Questions and answers: Requirements relating to notified bodies Revision 3 – October 2021

14/03/2022

The document, endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745, presents questions and answers on requirements relating to notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

Read the questions & answers published by the European Commission on 4 October 2021.

lsgilbert

Voir tous les articles

---

OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (14 mars 2022). Questions and answers: Requirements relating to notified bodies Revision 3 – October 2021. ELSIBI. Consulté le 12 octobre 2026 à l’adresse https://doi.org/10.58079/o5um

---

Étiquettes : EU LawEuropean UnionMedical devicesRegulation

• Article suivant Minutes – 9th Plenary meeting of the Expert Panel (22 September 2021)
• Article précédent The EUDAMED UDI/Devices and NBs & Certificates modules are open. Economic Operators and Notified Bodies can start entering data in EUDAMED on voluntary basis

Vous aimerez aussi...

• 0

  Guidance for the selection of Medical Devices (MD) and In Vitro Diagnostic Medical Devices (IVD) for Joint Scientific Consultations (JSC)

  03/06/2025

   par lsgilbert

   par lsgilbert · Published 03/06/2025

• 0

  Designation of EU reference laboratories for high-risk in vitro diagnostic medical devices

  13/02/2024

   par lsgilbert

   par lsgilbert · Published 13/02/2024

• 0

  EMA and WHO mark ten years of collaboration to advance global access to medicines

  22/11/2025

   par vroby

   par vroby · Published 22/11/2025