Hello Anon,
There probably needs to be some clarification on terminology from your post. First and foremost, a Research Use Only (RUO) product is not regulated as a medical device or in vitro diagnostic medical device, under any current regulation. They key word is "research" as these are not to be used in, with, or on humans or subjects. So the audit finding itself is not valid, because there is no requirement for RUO products to have any technically supportive data. The term "Technical Documentation" refers generally to the European Union regulation where there is a compilation of technical information related to the product. A Medical Device File (MDF) or Device Master Record (DMR) is the "recipe" and documentation needed to manufacture, produce, inspect, test, and other aspects associated with the finished medical device or IVD. The Design History File (DHF) or Design and Development Records (DDR) are the compilation of all of the research, design, and development activities associated with the product.
Going back to your post, if you are ISO 13485 certified and your own company's internal procedures require these RUO products to have a MDF/DMR, DHF/DDR, and/or Technical Documentation, then indeed this could be a valid internal audit finding. It would not be any external audit finding since again RUO products are not considered regulated medical devices or IVDs. There are different standards and guidance for compiling those different areas which is too much to cite in this forum post - depending on your regulatory jurisdiction this could be FDA QS Regulations, ISO 13485, EU MDR/IVDR, etc.
If the RUO product is being used for further manufacturing or testing purposes such as to be incorporated into a Laboratory Developed Test (LDT) or an in-house developed test, then the organisation may have customer requirements for compilation of MDF/DMR, DHF/DDR, and/or Technical Documentation. Again this should be clarified because RUO products are not regulated - so the requirements would fall back to your internal requirements or an external customer requirements. Final comment is you might want to go back to the internal audit finding to make sure the scope and requirement for these products are clearly defined as to why there is not sufficient technical information and what this technical information should actually constitute.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 08-Sep-2023 01:46
From: Erik Vollebregt
Subject: Technical documentation for RUO product
The requirements pertaining to the Medical Device File (MDF) are outlined in section 4.2.3 of ISO 13485:2016 which provides that the organization is obligated to create and maintain a comprehensive MDF for each medical device family. This file serves as a repository of all the essential documentation needed to demonstrate compliance with ISO 13485 and other applicable regulations. Applicable regulations is the magic concept here, because that wil determine what the file will really look like. And regulations that you may want to move to, e.g. IVDR at some point. You could start with the IMDRF STED format that is rather general still and then develop this into more detailed techical documentation for regions and type of device if that fits the strategy. There are specific requirements in the ISO standard too (against which the finding was raised in the first place) so make sure to at least meet those so the ISO auditor can tick his or her boxes.
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Erik Vollebregt
Partner
Amsterdam
Netherlands
Original Message:
Sent: 06-Sep-2023 18:00
From: Anonymous Member
Subject: Technical documentation for RUO product
This message was posted by a user wishing to remain anonymous
Hi everyone,
We are a company specializing in the design, development, and manufacturing of RUO products, and we hold ISO 13485 certification. We recently conducted an internal audit, which had a significant finding: a lack of technical documentation for our in-house manufactured product (RUO). This particular product currently lacks comprehensive technical records. We possess raw data pertaining to its performance; however, this data exists solely in spreadsheet format and lacks any associated protocols or formal reports.
In response to this audit finding, our QA department has initiated a CAPA project. The objective of this project is to retrospectively create comprehensive product technical documentation or a product file. Is there a specific guidance/standards that I need to look at so I know how and where to start? is there a certain format i have to follow for the technical documentation?
Your insights and recommendations in this regard would be greatly appreciated.
Thanks.