Is your software a medical device under the MDR regulation?

Is your software a medical device - SaMD?

Here's How to Find Out

hazard, harm, risk management, medical device development

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.

1. Does the SaMD have a medical purpose, i.e., intended to be used for diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury?

  • If yes, proceed to question 2.
  • If no, the product is likely not SaMD.

2. Is the SaMD stand-alone or an accessory to a medical device?

  • If stand-alone, proceed to question 3.
  • If an accessory to a medical device, proceed to question 4.

3. What is the intended medical purpose of the SaMD?

  • 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.

4. What is the intended purpose of the medical device to which the SaMD is an accessory?

  • 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.

5. Does the SaMD involve the use of patient-specific data to provide clinical decision-making recommendations?

  • If yes, proceed to question 6.
  • If no, proceed to question 7.

6. Does the SaMD involve the use of patient-specific data for a critical or urgent medical condition?

  • 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.

7. Does the SaMD incorporate artificial intelligence (AI) or machine learning (ML) algorithms?

  • If yes, proceed to question 8.
  • If no, proceed to question 9.

8. Is the AI/ML used for the interpretation of medical images, signals or physiological data?

  • 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.

9. Does the SaMD involve the processing of sensitive personal data (e.g., data concerning health, racial or ethnic origin, political opinions, religious or philosophical beliefs)?

  • If yes, proceed to question 10.
  • If no, proceed to question 11.

10. Does the processing of sensitive personal data relate to the clinical performance of the SaMD?

  • 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.

11. Does the SaMD require internet or network connectivity?

  • If yes, proceed to question 12.
  • If no, proceed to question 13.

12. Is the SaMD intended for remote diagnosis or treatment, or for the monitoring of vital physiological parameters?

  • If yes, the SaMD is likely to be classified as Class IIb.
  • If no, the SaMD is likely to be classified as Class IIa.

13. Does the SaMD fall under any specific rules or guidance for classification?

  • 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.

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This article serves as information only and does not represent an official or agreed position of CENIT Consulting. The opinions expressed in the article are solely those of the authors. Although every effort has been made to ensure the accuracy of the content, CENIT Consulting cannot be held responsible for any loss or damage that may result from relying on the information provided, except where such liability cannot be excluded by law.