Is it sufficient to use literature data only for MDR clinical evaluation of SaMD, or is own clinical data required?

Question

We are a software medical device manufacturer currently under risk class I MDD, but will be in risk class IIa under MDR. For the upcoming MDR certification, is it necessary to generate our own clinical data, or could it be sufficient to use literature data only for the initial certification? For example, can we argue that we are currently collecting our own data (PMCF study) and will have more evidence at a later date? Any experiences or recommendations would be appreciated.

Dr. Oliver Eidel · Accepted Answer

I recommend reviewing the MDCG 2020-1 guidance for Software Medical Devices. Clinical evaluation for software according to this guidance is based on three pillars: valid clinical association (scientific validity), technical performance, and clinical performance. If your literature data supports a valid clinical association and is from equivalent devices, it might be sufficient for initial certification. However, whether it's enough depends on your intended use and claims. If your MDR device has a history as an MDD device with no significant changes, also consider PMS data from the MDD device. In practice, notified bodies sometimes accept interim reports if you're actively collecting your own data, but this can vary. Be prepared to justify your approach based on your risk class, claims, and available data.

Answer

Have you checked the MDCG 2020-06 guidance for clinical evidence needed for MDD products? It explains what sort of data is needed. Generally, warning labels are the last resort for risk control. For clinical evaluation, the guidance emphasizes the need for sufficient clinical evidence, which can include literature data, but it needs to be robust and relevant. If you're using literature data, make sure it concerns equivalent devices. Also, if you're currently collecting your own data, sometimes an interim report can be sufficient depending on your notified body.

Is it sufficient to use literature data only for MDR clinical evaluation of SaMD, or is own clinical data required?

2 Answers

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