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Find out about the new EU MDR requirements and medical device classification criteria

Download the most comprehensive guide to the EU MDR prepared by our medical software development experts.

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Why should you ensure compliance with the EU MDR as soon as possible?

The new EU MDR requirements were introduced to improve medical device safety for patients and device operators.

The regulations have become stricter and more complex, resulting in a lengthened product development and launch process, which now requires a more strategic approach.

The transition period to comply with the EU MDR for manufacturers of devices already existing on the market is 4 years provided there are no changes to the product. The changes include all kinds of software updates, even security patches. Therefore, it’s recommended that compliance with the EU MDR be achieved as soon as possible.

The main aim of MDR regulations is to unify the market and tightened up the requirements

Here are some key changes brought by MDR in comparison to MDD:

  • More rigorous classification of medical devices defined as invasive or active.
  • Change to a higher and stricter classification of software, affecting the product and its use.
  • Extension of the scope of the Quality Management System to include, e.g., PMS system and PMCF.
  • Increased requirements for the designation of notified bodies.
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In this eBook we bring you tips and answers to questions like:

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What is MDR, and what does it mean for the sector?

First, we present the new directive and explain the most important definitions concerning the topic.
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What medical device classes are used in the EU?

Then we take a closer look at the medical device classification process and share some tips on how to do it right.

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How is software regulated in the MDR?

Here, we help you discover the most important rules to follow when developing medical software.
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How to assess if your software or your medical product falls under the new Medical Device Regulations?

Next, we provide you with a few tips to help you ensure that your product meets all the necessary demands.
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What changes for the European MedTech industry after the transition from MDD to MDR?

We also decipher the most significant adjustments and modifications that have come about with the new directive.
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How long is the transition period and to whom does it apply?

This section will tell you if you need to make any changes and, if so, how much time you have to make the transition.
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Do you need help with MDR compliance?

Here, we help you to figure out whether you need any assistance in achieving compliance with the MDR and summarise how we can support your process.
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Is your software a medical device under the EU MDR?

Finally, we give you some examples that will make the MDR regulation of your software clear and understandable.

Who we are

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Spyrosoft is an authentic, cutting-edge software engineering company, established in 2016. In 2022 and 2023, we were among the fastest-growing technology companies in Europe, according to the Financial Times.

We were founded by a group of tech Experts with established backgrounds in software engineering, who created an ‘engineer-to-engineer’ workplace, powered by enthusiasm, fairness and authentic relationships.

Having a unique offering, which bridges the gap between technology and business, we specialise in technology solutions for industry 4.0, automotive, geospatial, healthcare & life sciences, employee experience & education and financial services industries.

Meet our Expert
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Krzysztof Minicki

Director of Healthcare & Life Sciences

Working for the Medtech sector allows me to continuously challenge myself

I’ve been developing software for as long as I can remember. I started as a developer and migrated through many different roles in various IT projects. The knowledge and experience I gained allowed me to achieve a comprehensive understanding of the software development process and tailor it to clients’ needs. I’ve been using this skill for the past few years, i.e. when building medical products. I know how to swiftly and effectively develop software addressing all current regulations that’s both safe for patients and will provide them with tangible benefits.

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Learn more

Find out how to achieve compliance with the EU MDR. Get your free copy of our eBook:

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