Regulatory Resources
Clinical guidelines, MDCG guidance, FDA guidance, standards, and compliance tools
IMDRF/NCAR WG/N31: Medical Devices: Post Market Surveillance: National Competent Authority Report (NCAR) Pilot Plan; Implementing Material
Information document published 2015 by IMDRF.
Download PDFIMDRF/NCAR WG/N30: Medical Devices: Post-Market Surveillance -IMDRF National Competent Authority Report (NCAR) Pilot Plan
Information document published 2015 by IMDRF.
Download PDFIMDRF/MDSAP WG/N29: Clarification of the Term "Legal Entity" for MDSAP Recognition Purposes
Information document published 2015 by IMDRF.
Download PDFIMDRF/SaMD WG/N23: Software as a Medical Device (SaMD): Application of Quality Management System
Technical document published 2015 by IMDRF.
Download PDFIMDRF/MDSAP WG/N24: Medical Device Regulatory Audit Reports
Technical document published 2015 by IMDRF.
Download PDFIMDRF/RPS WG/N19: Common Data Elements for Medical Device Identification
Technical document published 2016 by IMDRF.
Download PDFIMDRF/MDSAP WG/N3: Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition
Technical document published 2016 by IMDRF.
Download PDFIMDRF/REGISTRY WG/N33: Principles of International System of Registries Linked to Other Data Sources and Tools
Information document published 2016 by IMDRF.
Download PDFIMDRF/Registry WG/N42: Methodological Principles in the Use of International Medical Device Registry Data
Information document published 2017 by IMDRF.
Download PDFIMDRF RPS WG/N45: Data Exchange Guidelines – Common Data Elements for Medical Device Identification
Information document published 2017 by IMDRF.
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