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Clinical evaluation requirements for Class I self-certified devices

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Guest Created:   Feb 25, 2021 Last commented:   Feb 26, 2021

Clinical evaluation requirements for Class I self-certified devices

If a class I self-certified medical devices manufacturer has minimal clinical evaluation data due to the fact that most of the devices have been designed and manufactured as equivalent to those from other manufacturers, which would be the best route to comply with clinical requirements according to the MDR? There are records regarding CAPAs, complaints and customer feedback available, but no data from clinical studies or PMCF. The company has been compliant with MDD from this point of view by stating that it was not necessary to conduct a clinical evaluation based on clinical data (literature route/ clinical investigation) caused by the use of an harmonised standard for the products.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Feb 26, 2021

In your case, you can perform clinical evaluation by proving the equivalence with devices already on the market. So, you need to make all required documentation according to Article 61 – Clinical evaluation and Annex 14 – Clinical evaluation and post-market clinical follow-up.

For more information, see:

For more detail on equivalence, please see guidance from the MDCG group: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en.pdf

You can see how necessary documents look like in our ISO 13485:2016 & MDR Documentation toolkit looks like:

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Feb 25, 2021

Feb 26, 2021