Create your Technical Documentation for EU MDR 2017/745

Recently we have experienced multiple successes in the submission of Technical Documentation under EU MDR and we want to help you go through this journey with as little burden as possible.

Use GSPR to start

I know this is maybe not really clear. The GSPR is the General Safety and Performance Requirements. You can see that within Annex I of the EU MDR. So now what to do with that?

I advise you to do a brainstorming and try to imagine what would be necessary to answer these requirements. For example for the second requirement and most of the next ones, the answer will be ISO 14971:2019 - Risk Management documentation (Risk Management Plan, Risk Management analysis, Risk Management Report). Maybe also IEC 62366 for usability. So you see, by doing the brainstorming, you will be able to try to put yourself in the shoes of the assessor and then your objective will be to create all these documents.

Now there are 24 requirements, so this may take some time to check each of them but no worries most of them will be not applicable to your product. So this may help.

YOUTUBE VIDEO - GSPR for medical devices

The creation of the evidence

Now that you know what should be created to answer the GSPR, you just need to start to create all these documents.

This may take some time. This may need also some resources like for performing some tests if you need a Biocompatibility report or Cybersecurity report.

This phase is important and I call it the "Creation of the puzzle pieces".

A Technical Documentation is the big picture will all the pieces of the puzzle on it. So before creating your technical documentation, you need to create the pieces of the puzzle.

Technical File structure

The next step is to structure your Technical File in a way that will satisfy the Notified Body. So before starting, ask your Notified Body if there is a specific structure they would like to see. Usually, they will send you a guidance or checklist that you would need to fill out. Use this checklist to structure your Technical Documentation.

Your Technical File Dossier should contain 2 things.

1. The file that summarizes all the information is called TECHNICAL DOCUMENTATION
2. The Annexes will contain all the evidence that you gathered.

The Notified Body then will check the summary file and inside the summary file, there should be the reference of documents that may be checked for a specific chapter.

So your role will be to show the auditor where to find this document. In which annex?

Youtube video - How to create your Technical Documentation?

Electronic structure

Now you may think that you will need to print everything but no. Create your technical file structure in your folder. You should have your technical File in a PDF format signed. And with this file, you should have a folder called Annex.

Inside the Annex folder, you will create a folder called Annex I - TITLE OF THE ANNEX. And the same for the other annexes.

Inside the Annexes you will then include a folder for topics like IFU, LABEL, CLINICAL EVALUATION, CLINICAL INVESTIGATION...

Inside each of these folders, you'll then include your evidence.

TEMPLATES

In case you don't want to bother with all this, we have created a Template Pack called PREMIUM PACK EU MDR 2017/745. LINK

It contains not only the template for the technical documentation but also templates for Clinical evaluation and risk management... Nearly all of what you need to start your technical file. And we structured that as described before.

Conclusion

In the case you need to create a Technical Documentation under EU MDR, you have the options below:

• Option 1: Learn from ANNEX II and ANNEX III of the EU MDR on what is expected for it and compile all this within your file
• Option 2: Use the Premium Pack which will make your journey a bit easier
• Option 3: Contact Easy Medical Device and we will help you with the process. Cost a bit more but you are sure to be CE-marked for your medical device.