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IMDRF Archive

IMDRF is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence.

IMDRF was born in October 2011, when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa to address the establishment and operation of this new Forum.

MDSAP

The Medical Device Single Audit Program (MDSAP) audit process is a consortium of IMDRF Regulators who established an operational program for a 'Single Audit Program' for medical devices, based on the IMDRF forum. MDSAP was designed and developed to provide an efficient yet thorough coverage of the Quality Management System requirements implemented by medical devices manufacturers. These requirements are based on ISO 13485 - Medical devices - Quality management systems, and the specific requirements from the medical device regulations of the Regulatory Authorities that are participating in the MDSAP.

MDSAP has been considered fully operational from 1 January 2019. For current information on implementation see the MDSAP website.

IMDRF technical documents
MDSAP code Document title Date posted Pages
IMDRF/AE WG/N43 FINAL:2020 Annexes (Edition 4.0) Annex A: IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes - XLSX (42kb) Annex B: IMDRF terminologies for categorized Adverse Event Reporting (AER): Type of investigation - XLSX (13kb) Annex C: IMDRF terminologies for categorized Adverse Event Reporting (AER): Investigation Findings ('what were the findings?') - XLSX (22kb) Annex D: IMDRF terminologies for categorized Adverse Event Reporting (AER): Investigation Conclusion - XLSX (14kb) Annex E IMDRF terminologies for categorized Adverse Event Reporting (AER) Health Effect - Clinical Signs, Symptoms and Conditions - XLSX (75kb) Annex F IMDRF terminologies for categorized Adverse Event Reporting (AER) Health Effect - Health Impact - XLSX (14kb) Annex G IMDRF terminologies for categorized Adverse Event Reporting (AER): Medical Device Parts and Component Terms and Codes - XLSX (29kb) 20 April 2020 23
IMDRF/MDSAP WG/N5 FINAL:2013 Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations - PDF (363kb) Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations - DOCX (313kb) 18 December 2013 32
IMDRF/MDSAP WG/N8 FINAL:2015 Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations - PDF (256kb) Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations - DOCX (154kb) 2 October 2015 53
IMDRF/AE WG(PDl)/N43 (Edition 3) FINAL:2019 Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes - PDF (488kb) Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes - DOC (285kb) Annex A: IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes - XLSX (60kb) N43 Annex A Reference Mapping - XLSX (41kb) Annex B: IMDRF terminologies for categorized Adverse Event Reporting (AER): Type of investigation - XLSX (14kb) N43 Annex B Reference Mapping - XLSX (10kb) Annex C: IMDRF terminologies for categorized Adverse Event Reporting (AER): Investigation Findings ('what were the findings?') - XLSX (30kb) N43 Annex C Reference Mapping - XLSX (20kb) Annex D: IMDRF terminologies for categorized Adverse Event Reporting (AER): Investigation Conclusion - XLSX (16kb) Annex E IMDRF terminologies for categorized Adverse Event Reporting (AER) Health Effect – Clinical Signs, Symptoms and Conditions - XLSX (218kb) Annex F IMDRF terminologies for categorized Adverse Event Reporting (AER) Health Effect – Health Impact - XLSX (19kb) N43 Annex D Reference Mapping - XLSX (11kb) 21 March 2019 20
IMDRF procedural documents
IMDRF code Document title Date posted Pages
IMDRF/MC/N2 FINAL:2019 (Edition 5) IMDRF Standard Operating Procedures - PDF (693kb) IMDRF Standard Operating Procedures - DOCX (161kb) 21 March 2019 30
IMDRF/MC/N39 FINAL:2015 IMDRF Strategic Plan 2020 - PDF (59kb) IMDRF Strategic Plan 2020 - DOCX (62kb) 2 October 2015 5
IMDRF information documents
MDSAP code Document title Date posted Pages
IMDRF/AE WG/N44 FINAL:2019 (Edition 2) Maintenance of IMDRF AE Terminologies - PDF (787kb) Maintenance of IMDRF AE Terminologies - DOCX (178kb) Appendix A: Request and Recommendation Form - XLSX (12kb) 27 June 2019 8
IMDRF/AE WG/N44 FINAL:2017 Maintenance of IMDRF AE Terminologies - PDF (224kb) Maintenance of IMDRF AE Terminologies - DOCX (172kb) 16 March 2017 8
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