August Round-up: UK MHRA Proposal to Increase Fees, Update on GMDN to EMDN Mapping, and More
30 August 2024
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10 September 2024Purpose
The IMDRF published an ‘Implementation Report’: HERE
The report outlines the ‘Implementation Levels’ of IMDRF technical documents in each participating country. This allows industry to more easily identify where there are divergences in international requirements. For example, which countries have implemented the UDI IMDRF guidance documents “as is”, which have implemented it with individual adjustments, and which countries did not implement it at all.
The full list of IMDRF Members (11), Official Observers (3), and Affiliate Members (14) is available: HERE
Implementation Levels
The possible levels are:
“Implemented: All relevant elements, concepts and principles of the IMDRF document are followed.
Partly Implemented: The IMDRF document has ben implemented in a modified way that a) does not include all relevant elements, concepts and principles of the IMDRF document or b) requires application of the document for a smaller range of products than outlined in the IMDRF document.
Not applicable: The implementation of a specific IMDRF document is not applicable in a country/region.
Not implemented: The process for the implementation of the IMDRF document has not yet started or is not completed.”
Table
The below table contains some of the Working Group documents as an example. Please download the IMDRF’s report for the full list.
| Working Group | Document | Implemented | Partly Implemented | Not Implemented |
|---|---|---|---|---|
| Adverse Event Terminology (AET) | IMDRF/AE WG/N43 FINAL:2021 (Edition 5) IMDRF terminologies for categorized Adverse Event Reporting (AER):Terms, terminology structure and codes | Australia Canada EU S. Korea Singapore UK USA Switzerland* | Brazil China Japan Argentina* | |
| Artificial Intelligence (AI) | IMDRF/AIMD WG/N67 FINAL:2022 Machine Learning-enabled Medical Devices: Key Terms and Definitions | Canada China EU S. Korea USA Switzerland* | Japan Singapore | Australia Brazil UK (NA) Argentina* (NA) |
| Principles of In Vitro Diagnostic (IVD) Medical Devices Classification | IMDRF/IVD WG/N64 FINAL:2021 Principles of In Vitro Diagnostic (IVD) Medical Devices Classification | Brazil Canada EU S. Korea Switzerland* | China Japan Singapore USA | Australia UK Argentina* (NA) |
| Medical Device Clinical Evaluation (MDCE) | IMDRF MDCE WG/N55 FINAL:2019 Clinical Evidence – Key Definitions and Concepts (formerly GHTF/SG5/N1R8:2007) | Australia Brazil China EU Japan Singapore USA Switzerland* | Canada S. Korea | UK Argentina* |
| IMDRF MDCE WG/N56FINAL:2019 Clinical Evaluation (formerly GHTF/SG5/N2R8:2007) | Australia Brazil China EU Singapore USA Switzerland* | Canada Japan S. Korea | UK Argentina* | |
| IMDRF MDCE WG/N57FINAL:2019 Clinical Investigation (formerly GHTF/SG5/N3:2010) | Australia Brazil China EU Japan USA Switzerland* | Canada S. Korea Singapore | UK Argentina* | |
| IMDRF MDCE WG/N65FINAL:2021 Post-Market Clinical Follow-Up Studies (formerly GHTF/SG5/N4:2010) | Australia EU Switzerland* | China Japan S. Korea Singapore USA | Brazil UK Argentina* | |
| Software as a Medical Device (SaMD) | IMDRF/SaMD WG/N10 FINAL:2013 Software as a Medical Device (SaMD): Key Definitions | Brazil Canada China EU Japan Singapore Argentina* Switzerland* | Australia S. Korea UK USA | |
| IMDRF/SaMD WG/N12 FINAL:2014 Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations | Brazil China EU Singapore Argentina* Switzerland* | Australia Canada Japan S. Korea UK USA | ||
| IMDRF/SaMD WG/N23 FINAL:2015 Software as a Medical Device (SaMD): Application of Quality Management System | Australia China EU Singapore USA Argentina* Switzerland* | Brazil Canada Japan S. Korea UK | ||
| IMDRF/SaMD WG/N41FINAL:2017 Software as a Medical Device (SaMD): Clinical Evaluation | Australia Brazil China EU Singapore USA Argentina* Switzerland* | Canada Japan S. Korea UK | ||
| Unique Device Identification (UDI) | IMDRF/UDI WG/N7 FINAL:2013 UDI Guidance: Unique Device Identification (UDI) of Medical Devices | Brazil China EU Singapore USA Argentina* Switzerland* | Japan S. Korea UK | Australia Canada |
| IMDRF/UDI WG/N48 FINAL: 2019 Unique Device Identification System (UDI system) Application Guide | Brazil China EU Singapore USA Switzerland* | Japan S. Korea | Australia Canada UK Argentina* |
*Official Observers are denoted with an asterisk (*) and “NA” is used to indicate when a specific IMDRF document is not applicable in a country/region.
