Medical Device Regulation (MDR) – Useful Links
• European Union (EU) Commission Website
• 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.
• Ongoing Guidance Development Within MDCG Subgroups (December 2020): This link provides Scope Group Deliverables, Consult prior to MDCG, and Planned MDCG Endorsements.
• 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.
• Competent Authorities for Medical Devices (CAMD) Road Map: This link provides the high-level Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Roadmap.
January 27, 2022
