Sam Lazzara
Trusted Information Resource
In other threads here, there has been some discussion about the similarities and differences between FDA Device Master Record (DMR) requirements per 21 CFR 820.181 and ISO 13485:2016 clause 4.2.3 Medical device file (MDF) requirements.
Below, I have copied and pasted the FDA DMR requirements:
820.181 Device master record. Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with Sec. 820.40. The DMR for each type of device shall include, or refer to the location of, the following information: (a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; (b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; (d) Packaging and labeling specifications, including methods and processes used; and (e) Installation, maintenance, and servicing procedures and methods.
For the 13485 4.2.3 requirements, please refer to your own copy. And please read the first sentence carefully; I believe it is the main reason that some have interpreted the DMR to be a subset of the MDF.
When I first read ISO 13485:2016, I wanted to believe the MDF requirements are the "same" as the FDA DMR requirements. After that, and until the issuance of the ISO 13485:2016 Handbook in 2017, I saw various (differing) opinions regarding this topic. Many sources indicated "No significant differences" or the like. And then, starting with the BSI 2016 FAQ document followed by an AAMI 2017 white paper, and culminating with the ISO 13485:2016 practical guide, my thoughts have evolved.
BSI ISO 13485:2016 Frequently asked questions (July 2016)
Clause 4.2.3 – Medical Device File What type of file does "Medical Device File" refer to? "Medical Device File" refers to both the device master record, and the technical documentation (technical file or design dossier). The requirements of this clause were previously documented in Clause 4.2.1 in ISO 13485:2003 and EN ISO 13485:2012.
AAMI Quality Systems White Paper Comparison of 21 CFR Part 820 to ISO 13485:2016 (February 2017)
Requirements are similar for maintaining a record or file for each type or model of device, which includes procedures and specifications for production processes, packaging, labeling, and quality assurance. The Regulation assigns the name "Device Master Record" to these records/files. The Standard assigns the name "Medical Device File."
Comment: The Standard lists the documents that would be included in the medical device file. The content of the medical device file would include the records contained within the device medical record, and additional requirements.
ISO 13485:2016 – Medical devices – A practical guide (ISO/TC 210) Edition 1 (2017)
In this guide, it is obvious that the MDF is a broader collection of documents than the FDA DMR.
MDF = DMR + DHF + TD + RMF + UEF
MDF, Medical Device File (ISO 13485:2016 clause 4.2.3)
DMR, Device Master Record (FDA 21 CFR 820.181)
DHF, Design History File (FDA 21 CFR 820.30(j) and ISO 13485:2016 clause 7.3.10 – no conflicts)
RMF, Risk Management File (ISO 14971 past, present and future)
UEF, Usability Engineering File (IEC/EN 62366-1:2015)
… which so far has led to pleasant silence from many 13485:2016 regulatory authority auditors.
Am I crazy? (probably but what else is new)
Below, I have copied and pasted the FDA DMR requirements:
820.181 Device master record. Each manufacturer shall maintain device master records (DMR's). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with Sec. 820.40. The DMR for each type of device shall include, or refer to the location of, the following information: (a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications; (b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications; (c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used; (d) Packaging and labeling specifications, including methods and processes used; and (e) Installation, maintenance, and servicing procedures and methods.
For the 13485 4.2.3 requirements, please refer to your own copy. And please read the first sentence carefully; I believe it is the main reason that some have interpreted the DMR to be a subset of the MDF.
When I first read ISO 13485:2016, I wanted to believe the MDF requirements are the "same" as the FDA DMR requirements. After that, and until the issuance of the ISO 13485:2016 Handbook in 2017, I saw various (differing) opinions regarding this topic. Many sources indicated "No significant differences" or the like. And then, starting with the BSI 2016 FAQ document followed by an AAMI 2017 white paper, and culminating with the ISO 13485:2016 practical guide, my thoughts have evolved.
BSI ISO 13485:2016 Frequently asked questions (July 2016)
Clause 4.2.3 – Medical Device File What type of file does "Medical Device File" refer to? "Medical Device File" refers to both the device master record, and the technical documentation (technical file or design dossier). The requirements of this clause were previously documented in Clause 4.2.1 in ISO 13485:2003 and EN ISO 13485:2012.
AAMI Quality Systems White Paper Comparison of 21 CFR Part 820 to ISO 13485:2016 (February 2017)
Requirements are similar for maintaining a record or file for each type or model of device, which includes procedures and specifications for production processes, packaging, labeling, and quality assurance. The Regulation assigns the name "Device Master Record" to these records/files. The Standard assigns the name "Medical Device File."
Comment: The Standard lists the documents that would be included in the medical device file. The content of the medical device file would include the records contained within the device medical record, and additional requirements.
ISO 13485:2016 – Medical devices – A practical guide (ISO/TC 210) Edition 1 (2017)
In this guide, it is obvious that the MDF is a broader collection of documents than the FDA DMR.
- It mentions that the MDF is sometimes referred to by other names, such as technical file
- It includes documentation relevant to design and development (which includes more than just "design output" documentation which is what I believe the FDA DMR equates to)
- Examples provided for MDF content include: clinical data; verification/validation data for device changes; standards applied and methods used and evidence that documents conformity with safety and performance requirements.
MDF = DMR + DHF + TD + RMF + UEF
MDF, Medical Device File (ISO 13485:2016 clause 4.2.3)
DMR, Device Master Record (FDA 21 CFR 820.181)
DHF, Design History File (FDA 21 CFR 820.30(j) and ISO 13485:2016 clause 7.3.10 – no conflicts)
RMF, Risk Management File (ISO 14971 past, present and future)
UEF, Usability Engineering File (IEC/EN 62366-1:2015)
… which so far has led to pleasant silence from many 13485:2016 regulatory authority auditors.
Am I crazy? (probably but what else is new)
