【转】DHF、DMR、MDF、DHR医疗器械文件要求与解读

一时失言乱红尘 2022-11-09 12:50 1116阅读 0赞

*  1、DMR：Device Master Record 器械主文档，法规条款：FDA QSR820.181
    
    2、DHR: Device History Record，法规条款：FDA QSR820.184
    
    3、DHF: Design History File，法规条款：FDA QSR820.30(j)
    
    4、MDF: Medical Device File，法规条款：ISO13485：2016 第 4.2.3

**DHF – Design History File**

The DHF is the design history file.

DHF是设计历史文档。

As you go through the design anddevelopment process for your medical device, the documentation that you createis going to be contained here.

它包含在完成医疗器械的设计和开发过程时所创建的文档。

According to the FDA, *the designhistory file shall contain or reference the records necessary to demonstratethat the design was developed in accordance with the approved design plan andthe requirements of this part* ([21CFR Part 820.30][])*. Each manufacturer shall establish and maintain a DHFfor each type of device.*

根据FDA的规定，设计历史文件应包含或引用必要的记录，以证明设计是根据批准的设计方案和21 CFR Part 820.30的要求制定的。每个制造商应为每种类型的器械建立和保存DHF文档。

The actual idea of the DHF is fairlystraightforward. In practice, that can be a bit of a challenge if you don’t compileit as you go.

DHF的实际意图相当简单。如果你在实践中不去编写它，那么提供该文档将比较困难。

You need to include or provide a referenceto all of the records related to the activities you did during the design anddevelopment process.

该文档需要包括或提供你在设计和开发过程中所做的活动有关的所有记录。

That means you need all of the user needsand design inputs you came up with at the start of the project.

这意味着你需要在项目开始时提出的所有用户需求和设计输入。

All of the design outputs that yougenerated to build the device.

为制成器械而生成的所有设计输出。

All of the [designverification and validation protocols and reports][].

所有的设计验证和确认的方案和报告。

Plus, all of design reviews that went alongwith all of that…and don’t forget everything for transferring the device tomanufacturing too.

此外，与此相关的所有的设计评审...不要忘记把器械转移到生产的过程。

Once you’ve gotten all of those documentscompiled into your DHF, the next acronym that needs to be tackled is the DMR.

一旦将所有这些文档编写到DHF中，需要解决的下一个首字母缩略词就是DMR。

**DMR – Device Master Record**

The DMR is the device master record.

DMR是器械主记录。

Everything you need to know to build andtest the device is contained here.

它包含了制造和测试器械所需的一切。

According to the FDA, *the DMR foreach type of device shall include, or refer to the location of, the followinginformation:*

根据FDA的规定，每种医疗器械的DMR应包括或提及以下信息的位置：

*(a)    **Device specificationsincluding appropriate drawings, composition, formulation, componentspecifications, and software specifications;*

器械规格，包括适当的图纸，成分，配方，组件规格和软件规格;

*(b)    **Production processspecifications including the appropriate equipment specifications, productionmethods, production procedures, and production environment specifications;*

生产工艺规范，包括适当的设备规格，生产方法，生产程序和生产环境标准;

*(c)    **Quality assuranceprocedures and specifications including acceptance criteria and the qualityassurance equipment to be used;*

质量保证程序和规范，包括验收标准和使用的质量保证设备;

*(d)    **Packaging and labelingspecifications, including methods and processes used; and*

包装和标签规格，包括采用的方法和工艺;

*(e)    **Installation,maintenance, and servicing procedures and methods.*

安装，维护和维修程序和方法。

*Each manufacturer shall ensure that eachDMR is prepared and approved in accordance with *[*21CFR Part 820.40*][21CFR Part 820.40]*.*

每个制造商应确保每个DMR按照21 CFR Part 820.40进行准备和批准。

Some parts of this should sound a lot likewhat you just got done compiling in the DHF.

这里的部分内容很像刚刚提到的DHF的编写。

The device specifications, [packaging][] and [labeling][] specificationswere part of the design outputs you created earlier.

器械规格，包装和标签规格是你之前创建的设计输出的一部分。

The production process specifications werepart of the [design transfer][] youdid earlier as well.

生产工艺规范是之前做过的设计转换的一部分。

Even the quality assurance procedures andspecifications were created earlier, because those include defining theacceptance criteria which is part of design output.

质量保证程序和规范也是早些时候创建的，因为其中包括作为设计输出一部分定义的接受标准。

The good news is that the FDA only requiresyou to reference the required items, not duplicate them.

好消息是，FDA只要求你参考所需的项目，而不是重复它们。

If you were really organized in thecreation of your DHF, it’s going to be really easy to reference that locationin your DMR.

如果你准备了要创建的DHF，那么在你的DMR中引用它将非常容易。

The difference between the DHF and the DMRis in that first letter – design vs. device.

DHF与DMR之间的区别在于第一个字母- 设计与器械。

The DHF is focused on the history of thedesign and ensuring it was done according to the FDA regulations.

DHF侧重于设计的历史，并确保按照FDA的规定进行。

The DMR is focused on the device andensuring you have all of the necessary items to build, test, package, andservice it.

DMR侧重于器械，确保拥有制造，测试，包装和维护所有必需的项目。

Now that you’ve designed the device (DHF)and have the recipe to build and test it (DMR), it’s time to actually make thedevice.

现在你已经设计了该器械（DHF）并且拥有了“处方”来构建和测试它（DMR），现在是时候制造器械了。

That’s when the DHR comes into play.

也就轮到DHR发挥作用了。

**DHR – Device History Record**

The DHR is the device history record.

DHR是器械历史记录

Everything you did to make the device iscontained here.

它包括制造器械所做的一切事情。

According to the FDA, *the DHR shallinclude, or refer to the location of, the following information:*

根据FDA的规定，DHR应包括或参阅以下信息：

*(a) The dates of manufacture;**生产日期*

*(b) The quantity manufactured;**生产数量*

*(c) The quantity released fordistribution;**交付数量*

*(d) The acceptance records whichdemonstrate the device is manufactured in accordance with the DMR;* 证明器械的制造符合DMR的检验记录

*(e) The primary identification label andlabeling used for each production unit; and*

主要的标签和对应每个产品的标签;

*(f)     **Any unique deviceidentifier (UDI) or universal product code (UPC), and any other deviceidentification(s) and control number(s) used.*

任何唯一的器械标识符（UDI）或通用产品代码（UPC），以及使用的任何其他器械标识和控制编号。

*Each manufacturer shall establish andmaintain procedures to ensure that DHR's for each batch, lot, or unit aremaintained to demonstrate that the device is manufactured in accordance withthe DMR and the requirements of this part.*

每个制造商都应建立和保存程序，以确保每个批次或单位的DHR都能确保证明该设备是按照DMR和本部分的要求制造的。

The device history record is literally thehistory of the device.

器械历史记录字面意思就是是器械的历史。

Everything that you complied in the DMR wasused to make the device.

制作设备的所有内容都编写在DMR中。

The history and information on how you madethe device in accordance with the DMR is stored in the DHR. Much like the DHFis the history of the design, the DHR is the history of the device.

根据DMR制作设备的历史和信息都记录在DHR中。就像DHF是设计的历史一样，DHR是设备的历史。

**DHF vs. DMR vs. DHR**

While these three acronyms can seeconfusing and easily interchangeable when you first hear them, if you look atthe actual terms, they’re surprisingly descriptive.

虽然这三个缩写词在你第一次听到时可能会感到困惑并且很容易混淆，但如果看一下实际的术语，它们会有惊人的描述性。

DHF - Design History File DHF-设计历史文档

DMR - Device Master Record DMR –器械主文档

DHR - Device History Record DHR –器械历史记录

You start with the history of the design,which leads to the record of how to build and test the device, which leads tothe history of the device you actually made.

从设计的历史开始，引向构建和测试器械的记录，再引向制造设备的实际历史。

If you’re like me, the part you mix up themost is when the D stands for design vs. device.

你可以像我一样，最容易混淆的部分是D，代表设计和器械。

I keep them straight by remembering that Ineed a file for the design and a record of the device.

我是这样记的：我需要一个设计的文档和器械的记录。

When I see the R at the end, I know it’sdevice related.

当我看到最后的R时，我知道它是与器械相关的。

Hopefully that simple trick will help clearup any lingering confusion.

希望这个简单的技巧会有助于消除长久的困惑。

[21CFR Part 820.30]: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=820.30
[designverification and validation protocols and reports]: https://blog.greenlight.guru/design-verification-and-design-validation
[21CFR Part 820.40]: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.40
[packaging]: https://blog.greenlight.guru/medical-device-packaging-misconceptions
[labeling]: https://blog.greenlight.guru/medical-device-labeling-misconceptions
[design transfer]: https://blog.greenlight.guru/medical-device-design-transfer