The Difference Between IVDR and MDR in the EU

The Difference Between IVDR and MDR in the EU

The European Union's regulatory framework for medical devices can be quite perplexing, especially for startups venturing into the healthcare sector for the first (or even 10th) time. Knowing whether your product falls under In Vitro Diagnostic Regulation (IVDR) 2107/746 or Medical Device Regulation (MDR) 2017/745 can be overlooked. Everyone knows about MDR regulations but today let’s take a look at IVDR and if it might apply to your product

What is an in vitro diagnostic (IVD)?

In vitro diagnostic (IVD) devices are tools used to perform tests on samples (such as blood, urine, or tissue) taken from the human body. For context, “in vitro” means “outside of the living body in an artificial environment”. These devices are essential for diagnosing diseases, monitoring patients' health, informing treatment decisions, and ensuring the safety of blood and blood products. Examples include pregnancy tests, blood glucose monitors, and HIV test kits. IVDs are specifically governed by the EU's In Vitro Diagnostic Regulation (IVDR 2017/746) which is different from, albeit very similar to, MDR 2017/745.

IVD vs. MDR: Spotting the Difference

The main distinction between IVDR and MDR regulated devices lies in their application. While IVDs are used for analyzing biological samples, MDR regulated devices (under MDR 2017/745) include a broader range of products intended for diagnosis, prevention, monitoring, treatment, or alleviation of disease directly on a patient. This encompasses everything from surgical instruments to implantable devices and even certain software.

The most important aspect of determining if your product is an IVD comes from the type of data being collected, analyzed or transformed for the user. IVD devices are concerned specifically with biological samples. This can be blood, tissue, urine, breath, or other types of biological samples. A key note too is that even if your product isn’t directly sampling from these sources, if they use data from these types of samples they can also be considered an IVD.

Software as a Medical Device: IVD vs. MDR

When it comes to medical device software (MDSW), the classification under IVD or MDR depends on its intended purpose. For IVD, SaMD is used to analyze biological samples, whereas, for MDR, it directly supports or influences patient care more generally. MDCG 2019-11 provides detailed criteria for the qualification and classification of software, guiding manufacturers on how to determine if their software product is an IVD, a medical device under MDR, or neither. Take the quiz below if your software is governed under IVD or MDR:

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MDCG 2019-11 outlines specific decision steps to determine if your device is a MDSW or not.

Using this decision tree, you can easily determine if your product is an IVD MDSW or one governed by MDR 2017/745.

FormlyAI: Your Partner in Medical Device Certification

At FormlyAI, we understand the complexities of MDR medical device certification. Our service provides a streamlined, efficient path to CE marking and all the tools to ensure your medical device adheres to all necessary EU regulations. All for a fraction of the cost of using traditional consultants. This way you can build your compliance documentation and apply for CE marking in a matter of weeks, not years.  

Learn more about our software and accelerate your path to CE marking with Formly.