MDCG 2020-3 rev.01: Key Takeaways

🔹 This guidance addresses significant changes for devices under the transitional provision of MDR Article 120.

🔹 Focuses on changes in design or intended purpose of medical devices covered by MDD or AIMDD certificates.

🔹 Clarifies that these 'significant changes' should be assessed case-by-case.

🔹 Aimed at providing regulatory clarity to stakeholders in the medical device industry.

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