The draft standardisation request for MDR and IVDR was submitted to the Committee on Standards with the need to provide an adequate legal basis for the development of harmonised European standards and been issued to CEN and CENELEC, the European Standardisation Organisations.
Annex I of this request lists the existing standards to be revised, and new standards to be drafted under the MDR while Annex II of this request lists the existing standards to be revised, and new standards to be drafted under IVDR