Medical Device Regulation (MDR) - Useful Links
• European Union (EU) Commission Website
https://ec.europa.eu/health/home_en
• Medical Device Coordination Group (MDCG) Guidance: This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 in vitro Diagnostic Medical Devices (IVDR) on in vitro diagnostic medical devices.
https://ec.europa.eu/health/md_sector/new_regulations/guidance_en
• Ongoing Guidance Development Within MDCG Subgroups (December 2020): This link provides Scope Group Deliverables, Consult prior to MDCG, and Planned MDCG Endorsements.
https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_ongoing_guidancedocs_en.pdf
• Implementation Rolling Plan (December 2020): This page provides Rolling Plan which contains a list of identified essential implementing acts and other relevant initiatives that the Commission has adopted or intends to adopt in the future.
https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_rolling-plan_en.pdf
• Competent Authorities for Medical Devices (CAMD) Road Map: This link provides the high-level Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Roadmap.
https://www.camd-europe.eu/regulatory/medical-devices-regulation-vitro-diagnostics-regulation
January 27, 2022
