Medical device CE marking

New forms for Notified Bodies in the scope of the MDR and the IVDR

2021-07

On July 15, the European Commission published 4 new forms for Notified Bodies in the scope of the MDR and the IVDR:

  • MDCG 2021-15: Application form to be submitted by a conformity assessment body when applying for designation as notified body under Regulation (EU) 2017/745 on medical devices (MDR)
  • MDCG 2021-16: Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)
  • MDCG 2021-17: Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
  • MDCG 2021-18: Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)

The documents can be downloaded in our library (see above)

Source: European Commission