Format & Content of a Medical Device File (MDF) - ISO 13485:2016, Clause 4.2.3

This live-streaming video covered the format and content requirements for a medical device file (MDF). The requirement is found in ISO 13845:2016, Clause 4.2.3. However, we did not create a procedure for this until recently: https://medicaldeviceacademy.com/medical-device-file-procedure/ The reason is that the US FDA required a Device Master Record (DMR) instead (i.e., 21 CFR 820.181). However, the FDA is incorporating ISO 13485 by reference and they feel there is no need to define the MDF. The standard does not define the format and content either. Therefore, best practice is to create an index for your MDF that complies with the only guidance on technical documentation (GHTF/SG1/N011:2008): https://www.imdrf.org/sites/default/files/docs/ghtf/archived/SG1/technical-docs/ghtf-sg1-n011-2008-principles-safety-performance-medical-devices-080221.pdf Many of the standards we use are based upon these early GHTF guidance documents. The global harmonization task force (GHTF) was disbanded, but all of the documents are still available on the International Medical Device Regulators Forum (IMDRF) website. Ther high-level sections of your MDF should include the following: 1. Device Description & Product Specification, including variants and accessories 2. Information supplied by the manufacturer (i.e., IFU and labeling) 3. Design and manufacturing information (I forgot to mention this in the live-streaming video) 4. General Safety & Performance Requirements 5. Benefit/Risk Analysis & Risk Management File 6. Product Verification & Validation 7. Post-Market Surveillance Documentation 8. Administrative Details As I mentioned in the live-streaming, you should refer to the following standards for help: #2 - ISO 20417:2021 and ISO 15223-1:2021 #5 - ISO 14971:2019 and ISO/TR 24971:2020 #7 - ISO/TR 20416:2020 See next week's live-streaming for information about the "design and manufacturing information" to include in your MDF.

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