Am I a Medical Device? A Strategic Guide on EU Medical Device Classification
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The European Union (EU) medical device market is a labyrinth of regulations that can baffle even the most seasoned medical device makers. If you find yourself pondering, "Does my product even qualify as a medical device?" you're not alone. This quick guide is designed to detangle the EU medical device landscape so you can navigate your medical device classification while breathing a little easier. Recognizing the category your product falls under is not just about compliance—it's about carving a successful niche in the market and steering clear of regulatory pitfalls.
So - What is a Medical Device in the EU?
A medical device, in the eyes of the EU, encompasses a broad array of items, from simple tongue depressors to the most sophisticated programmable pacemakers. The easiest way to determine if your product is a medical device is to look closer at what purpose it serves. This is often called its “intended purpose” which the EU Medical Device Regulations (MDR) 2017/745 define as:
the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use, or in promotional or sales materials.
According to those same regulations, medical devices are instruments, apparatuses, machines, software, or other articles intended for medical purposes such as diagnosis, prevention, monitoring, treatment, prediction, prognosis, or alleviation of a disease, injury or disability. If your device is even tangentially related to any of these functions it’s worth taking time to read the rest of this article.
The classification of medical devices is not arbitrary; it's a meticulous process that weighs the intended purpose against the potential risks involved.
What About Software?
Good question. Software as a medical device (SAMD), sometimes called Medical Device Software (MDSW), has been a hot topic for some time and unfortunately software is one of the great mysteries of medical device regulations that is still being unraveled. The issue lies in the fact that software can have a multitude of functions within or related to medical devices.
Software can directly control a (hardware) medical device (e.g. radiotherapy treatment software), can provide immediate decision-triggering information (e.g. blood glucose meter software), or can provide support for healthcare professionals (e.g. ECG interpretation software). Are all of these software types regulated in the same way? In a basic sense, yes, depending on their device classification.
However, it is important to clarify that not all software used within healthcare is qualified as a medical device. For example, “Simple search”, which refers to the retrieval of records by matching record metadata against record search criteria or to the retrieval of information does not qualify as medical device software (e.g. library functions). Also, a task such as e-mailing, web or voice messaging, data parsing, word processing, and back-up is by itself not considered as having a medical purpose.
Medical device software is software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical device” in the MDR, regardless of whether the software is independent or driving or influencing the use of a device. Fortunately, the Medical Device Coordination Group (MDCG), a group tasked with providing more expansive guidance on medical device regulations in the EU, has provided a guidance document for the purpose of explaining how to qualify software as a medical device. Click here to view MDCG 2019-11 Guidance on Qualification and Classification of Software.
EU Medical Device Classification Spectrum
As we mentioned, the EU categorizes medical devices into classes that reflect their intended use and associated risks:
- Class I: Low risk (e.g., non-sterile bandages)
- Class IIa and IIb: Medium risk (e.g., dental fillings, ultrasound scanners)
- Class III: High risk (e.g., implantable pacemakers)
Each class carries its own set of regulatory requirements, with Class III devices subjected to the most stringent evaluations and Class I devices having the most lenient requirements. Understanding where your product fits within this framework is essential for ensuring regulatory compliance and market readiness.
A great resource for determining your device class is the MDCG Guidance 2021-24 which has some handy flow charts for determining what the class your device will be. Below is an excerpt of the flow chart related to Rule 11 which helps to determine the class of your software medical device.
When Your Product's Medical Device Classification Is Borderline
The status of your product as a non-medical device today does not cement its classification for eternity. Several factors can prompt a reevaluation:
- Regulatory Shifts: The EU's regulatory environment is dynamic. Staying informed about changes is critical to maintaining the correct classification for your product.
- Product Evolution: Any alterations in design, intended use, or functionality can trigger a reclassification.
It is important to keep up to date on new regulatory releases and the market for your product which may come under increased scrutiny from regulators. Setting yourself up for success and being aware of future requirements is an excellent starting point should you fall within the realm of medical device regulations.
Strategies to Prevent Unintended Medical Device Classification
You may be asking yourself how to avoid falling into the deep hole of medical device regulations by keeping your product from being classified as a medical device. To prevent your product from inadvertently crossing into medical device territory, consider these strategies:
- Intended Use Clarity: Articulate your product's purpose with precision. A claim of general wellness is less likely to be classified as medical compared to specific health-related claims. Make sure to avoid any words or phrases contained in the definition of a medical device as defined by EU MDR 2017/745 regulations.
- Regulatory Framework Knowledge: Immerse yourself in the regulatory landscape. Understanding the boundaries can inform your product design and development decisions.
- Review Classification of Other Medical Devices: A manual on classification and qualification of borderline medical device products was published in 2019 that provides a nice guide for how other medical products have been treated. Also, check your competitors and see if they have undergone medical device CE marking.
Feeling confident in your device classification?
Still Unsure? Let Us Help.
If your product is indeed a medical device, securing a CE mark is your golden ticket to the EU market.
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.
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