On this blog post, I want to help most of the people that need support to structure their new Medical Device Technical Documentation or Technical File.
Maybe you have seen it but the new MDR 2017/745 provides a clear structure of your technical documentation now. When before this was not so clear with the MDD 93/42/EC.
I will go through each section and try to give you some information on what is expected. For those that need more, I also created a template of the Technical Documentation Medical Device compliant to the MDR 2017/745.
So let’s discuss it and then let me know if you have some comments.
Table of Contents
Who will review your Technical Documentation?
This is an important question. You may think that this document is public but in reality, this document will be reviewed only by medical device experts from the authorities and your Notified Body (TÜV SÜD, BSI…9. In fact, this is the objective to create a Technical Documentation.
In the case of Class I (Self-certified) product, this document is still necessary in case of a review made by your competent authorities. So don’t think that because of self-certification you are not obliged to get it done.
In case of a product higher than pure class I, then there will be a need for a review made by your Notified Body that you should have selected. (I am including here class I sterile, with measuring function or reprocessed)
To identify which Notified Body is approved for MDR 2017/745, you should visit the NANDO database. Check that here.
This review can be really tough, so I suggest you to follow some of the requirements I provide below to be able to stay in compliance with the requirements.
Where can you find the Technical Documentation information?
First, you need to know that the EU MDR 2017/745 is providing a clear view of what should contain a technical file when the MDD 93/42/EC was not so structured.
Fortunately, IMRDF or GHTF created a template called STED (Summary Technical Documentation medical device) to help organize all the information but this was not mandatory per legislation. It was just good practice.
There is also another guidance released by IMDRF on Tech File structure for nIVD or non-In-Vitro Diagnostic products. This is compiling requirements from a lot of countries to harmonize this on 1 document. I would not recommend it if you are just starting your business and if you focus only on Europe.
For the MDR requirements, you need to go to Annex II and Annex III to see the requirements:
What is great with the new EU MDR is that the Technical Documentation information is provided with a clear title but for the content, this depends on a lot of things.
This would be then easier for a Notified Body to review it as the content would be the same for all manufacturers. Or nearly the same as you still have some flexibility.
What is the structure of a Technical Documentation?
As mentioned, the technical file is described in Annex II and III of the MDR 2017/745.
Below I will try to explain to you what is expected in each of the sections. But this is really a generic explanation as there can be some differences following the class and nature of your product.
A pacemaker technical documentation will not be the same as a surgical instrument file. So you should still be a bit creative and have some common sense. The topic that will be discussed below is really the items expected by the regulation.
Another thing before to start. The technical file should be considered as a controlled document. I will not discuss this point here, but you will need to track the versions and the changes so it is important to also include that on your file (Approvers, reference number…)
So now, let’s jump in..
In this first section, you need to introduce your device. This will provide a high-level understanding of the full technical documentation as here you will provide some information as Intended use, product name, reference numbers, variants, product classification, conformity assessment …
This is really an important section to have a broad understanding of your product and also to get the different references linked to it.
For example the Basic UDI-DI and the UDI. This can be a tricky section if your product is composed of multiple accessories or is provided on multiple configurations or variants.
Check my article on UDI to understand what I mean. Link.
In this section, you will also discuss your device generation and the other similar products on the market. Same as what you should find on the State-of-the-art section of a CER.
When someone will read this section, he should clearly understand the scope of your product. Then the next section will be clear for them.
Labeling/instruction for use
This part of the technical file is important. You remember in section 1 you described the product. What is important here is that the wording you used in section 1 is similar to what is written in the instruction for use or the label. A mismatch can create some confusion.
What is expected also if to provide a copy of the exact labels and IFUs with version numbers etc…
I recommend you to create a table with different products and document references in this section and then place true documents as an annex. This will make the life of the reviewer easy.
For each reference you’ll list, you should provide a copy of the Instruction for Use or of the Label. So if you have many, this can take some pages of your technical file.
Be careful, languages can also be a challenge as you have to provide the different documents with the official EU language of the country where you are selling your medical device.
As all the information on the technical documentation is linked. The label and IFU information should also match the requirements of the GSPR section. You’ll see what is GSPR in the next sections.
Podcast on Label Q&A
I have made a presentation during the MDR & IVDR Virtual Summit organized by Greenlight Guru.
The topic was “How to create the label for your product?” and there were so many questions, that I have decided to create a podcast episode to answer them.
Check show notes on YouTube to get more information.
Design and manufacturing information
This section is always tricky. Some medical device manufacturers are starting to design their products without a real Quality Management System structure from the beginning which makes it difficult to show compliance to this section retrospectively.
But if you have made your job right, you can then provide information about the design process with the different milestones you reached. A reference to a procedure can be great.
You can mention the different design stages related to the product, but you may also need to provide a link to those documents. So a table with a reference number to a controlled document is recommended.
When I say a controlled document, this means a document that you can track on your quality management system. Something with a reference number, a version, a place where we can see who approved it.
For the manufacturing information, this is important to have a high-level schematic of how this product is produced. A flowchart would make sense.
More your information will be clear, fewer questions you’ll receive from your Notified Body. So I recommend you to use a third party to evaluate if this is understandable.
The problem with a Notified Body question is not the question, it is the time that you will lose to finalize the review. More questions there is, less time the reviewer will have to finalize your dossier. Why?
Because while you will work on the answer to the question, he will start to work on another dossier. So you are back in the queue.
In this section, you’ll need also to talk about the different entities you are using for the realization of your product. For example, you should mention the entity that performed the design in the case not done by you.
Same if you are the legal manufacturer but not the manufacturer. I am thinking for example of companies that need the support of other entities to manufacture the product for them.
Additionally, you should also list your critical suppliers as the entities performing sterilization, cleaning, final inspection, assembly, packaging…
General Safety and Performance Requirements (GSPR)
GSPR is replacing the Essential Requirements that were on the MDD Annex I. There are some differences in the wording and also some new requirements.
So if you already have your previous essential requirements, don’t scrap it now. You can still upgrade them to the GSPR that you can find on annex I of MDR 2017/745.
If you launch a medical device for the first time in the EU, then maybe you don’t know how to structure your GSPR checklist. Don’t worry, I do provide a template for you. This is a template that you should fill by providing a proof for all the 23 requirements listed. Check my shop.
This is section is important as this is to define the risks related to your products. For medical device companies, this is following ISO 14971.
So you need to have a procedure for risk management and then issue some risk assessment for your products. This risk assessment can have multiple formats but the most known one is the FMEA format.
You will then identify the risk related to your products. In case of high risk, then you’ll need to mitigate it with some actions. But this may be the subject of another blog post as this can be complicated.
The MDR is providing some important wording coming from the MDR 2017/745. So this is important to include them in this section to be sure to be compliant to it.
Product Verification and Validation
I think this section will be the most important one to prove the safety and performance of your product. So stay focused.
This section is related to the product itself in terms of all the tests that you should do to provide evidence of:
- Safety in terms of chemical components
- Safety in terms of electricity
- Stable when stored on normal conditions
So be patient when you are building this section of the technical documentation as you will have to review each of those elements and provide a piece of evidence that you comply with the requirements. Many of the elements mentioned on annex II can be non-applicable So if this is the case, you just need to write N/A and maybe provide a justification when this can be not obvious.
For example, there are some combination products or products that use animal tissue or products that contain CMRs. If this is applicable you should complete the related section on the Technical Documentation.
As mentioned previously, clearer you are, fewer questions you’ll receive from your Notified Body. So quicker you’ll be able to place your product on the market.
Here we talked mainly of pre-clinical studies, but you’ll need also to include the Clinical Evaluation information of your product. All the clinical data are critical to proving the safety of your product. Without clinical data, you will not be able to get approval from your Notified Body.
If you want to know more about Clinical Evaluation Reports, I have interviewed Helene Quie on my Podcast and she will explain to you the importance of Clinical Data. See below
Podcast interview on Product Equivalence
Podcast interview on Sufficient Clinical Data
Post-market surveillance (PMS)
Finally, we arrive at the last section of the Technical Documentation which is related to annex III of the MDR. This is specific to Post-market Surveillance.
We can say that the MDR is now focusing a lot more on PMS. There is now an emphasis t to perform a proactive review of the performance of your product.
In this section, you then need to provide the PMS plan, the PMCF plan for residual risks, the PSUR. All this information should be available for review on your technical documentation.
Same as what I advised previously, you can also list some documents and then attach them in the annex. This will be more convenient for the reading phase.
PMS is really a big topic, so a set of procedures should also be created on your Quality Management System. Don’t forget that your procedures should also reflect the requirements of MDR.
Podcast Interview on PMS
Subscribe to my Youtube Channel to get notified of my next videos
Podcast Interview on PMS Tool
Ivan Perez Chamorro, CEO of MedBoard is on my podcast. He introduces to us a new feature that will help you to perform your PMS in an easier way.
Technical Documentation Medical Device Templates
So we arrived at the end. I can imagine that now you understand there is a lot of work to gather all this information.
To help you I also created some templates for technical documentation and GSPR checklist.
This will help you to have the right structure for your technical documentation and some guidance is provided to help you understand what is expected in each section. You can get it here.
If you need some support to prepare your Technical Documentation or to review them, don’t hesitate to contact me.
I will be happy to discuss your project with you. Just click the Red Phone logo below to activate a messenger chat.
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Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don’t hesitate to contact him at firstname.lastname@example.org or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.