Update of MDCG 2022-11 Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements

The Medical Device Coordination Group (MDCG) endorsed MDCG 2022-11 Rev.1, an update of the position paper with the notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements. The update includes a new section, “Call to notified bodies to streamline the certification process”, and a revision of the section “Call to manufacturers to transition to the Regulations and submit their applications for certification without further delay”. For more, see the Commission’s webpage on Guidance.