ESR vs GSPR

ESR vs GSPR “The essential requirements (ER) are the key elements to compliance with MDD and AIMDD. The new regulation EU MDR replaces the essential requirements (ER) by general safety and performance requirements (GSPR).

This means the manufacturers must demonstrate conformity with the general safety and performance requirements and other legal requirements, such as those relating to quality and risk management, laid down in this Regulation.

General safety and performance requirements (EU MDR) are almost similar to Essential Requirements (MDD), there are some additional requirements and some expanded requirements, and some new topics are introduced in GSPR.”

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