MDCG 2020-3 Rev.01 Published – Significant Change Guidance 👍

Key points:

🔹 Clinical evaluation: The definition of clinical evaluation has been clarified.

🔹 Postmarket surveillance: The requirements for postmarket surveillance have been strengthened.

🔹 Risk management: The requirements for risk management have been clarified.

🔹 Clinical data: The requirements for clinical data have been clarified.

🔹 Software: The requirements for software have been clarified.

🔗 Original Document:  https://health.ec.europa.eu/system/files/2023-05/mdcg_2020-3_en.pdf