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Legal Checklist Medical Devices

The Checklist Medical Devices is a checklist to verify if the instructions for use, packaging, marking & labelling, technical file and declaration of conformity of your medical device complies with the relevant requirements of the European Union.

Essential checklist for all businesses that sell medical devices within the European Union to pass customs with no delays, decrease liability, increase safety and be able to sell your medical device within the EU. You want to import, trade and/or sell your medical device on the European market? Do you want to make sure that your instructions for use, packaging, technical file, product marking & labelling and declaration of conformity comply with the requirements of the European Union to avoid problems at customs or to decrease liability? We have developed this checklist to make it happen.

Gain confidence when selling your medical device on the European market
Verify if your instructions for use, packaging, technical file, product marking & labelling and declaration of conformity comply with the requirements of the European Union.

With the checklist you can verify if your instructions for use, packaging, technical file, product marking & labelling and declaration of conformity complies with:

Regulation (EU) 2017/745 relating to Medical Devices, and
Directive 93/42/EU on Medical Devices

For questions, please contact us at info@instrktiv.com.

Money Back Guarantee

All our checklist have a 14-day, no-reason-required guarantee. So if you are not satisfied for any reason, just let us know and we’ll refund your money. As we believe that our product really helps you to create better instructions, we don’t think it’ll come to that. But as soon as you have any doubts whether our product is the right fit for you, just put your mind at ease. We will help you to get the results you want, or we will give you your money back!

Legal Checklist Medical Devices

€199

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Lothar Naujokat

Director, HANNETS

“The Instruction Manual Template helped our engineers to create the user manuals for our latest product. It contains all the information you need to create your own compliant manuals, so you don’t have to outsource this! It is such a time saver!”

Philip Olsson

CEO, ISOVOX Sweden

“The factory manuals always need to be redone. This was a daunting task for us: we never knew where to begin and at the end we were not sure if the manual did comply. The User Manual Template provides us all relevant information so we can create compliant instructions and decrease our liability.”

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