Is your software a medical device - SaMD?
Here's How to Find Out

Are you having trouble determining whether your app or software qualifies as a medical device under the MDR regulation, and how it should be classified? We’re here to help!
Our easy-to-use questionnaire can guide you through the classification process in just a few simple steps. Simply answer a few questions and you’ll be on your way to determining the proper MDR classification for your software.
Software as a Medical Device (SaMD) refers to software intended for use in the diagnosis, treatment, or prevention of disease or other medical conditions, that operates on general-purpose computing platforms and is not part of a hardware medical device.
- If yes, proceed to question 2.
- If no, the product is likely not SaMD.
- If stand-alone, proceed to question 3.
- If an accessory to a medical device, proceed to question 4.
- If the intended medical purpose is low-risk, the SaMD is likely to be classified as Class I.
- If the intended medical purpose is moderate- to high-risk, proceed to question 5.
- If the medical device is invasive, active, or implantable, the SaMD is likely to be classified as Class III or IIb.
- If the medical device is non-invasive and non-active, the SaMD is likely to be classified as Class IIa or higher.
- If yes, proceed to question 6.
- If no, proceed to question 7.
- If yes, the SaMD is likely to be classified as Class III.
- If no, the SaMD is likely to be classified as Class IIa or higher.
- If yes, proceed to question 8.
- If no, proceed to question 9.
- If yes, the SaMD is likely to be classified as Class III or IIb.
- If no, the SaMD is likely to be classified as Class IIa or higher.
- If yes, proceed to question 10.
- If no, proceed to question 11.
- If yes, the SaMD is likely to be classified as Class III or IIb.
- If no, the SaMD is likely to be classified as Class IIa or higher.
- If yes, proceed to question 12.
- If no, proceed to question 13.
- If yes, the SaMD is likely to be classified as Class IIb.
- If no, the SaMD is likely to be classified as Class IIa.
- If yes, follow the specific rules or guidance for classification.
- If no, the SaMD is likely to be classified as Class IIa or higher.
While our questionnaire can help guide you in the classification of your software as a medical device, we understand that the MDR classification process can be complex, and the tool may not be able to provide a definitive classification in all cases.
Therefore, if you’re still in doubt or have any questions, we encourage you to seek professional advice and review the applicable regulations to ensure proper classification. Our team of experts is also available to assist you in the classification process.
Please feel free to contact us for any assistance or support you may need.