Module 16 2024

10/17/2024

Important Definitions – Significant Changes

Following MDR Article 120 significant changes are those device modifications that are not allowed in the extended transition period for devices covered by Notified Body certificates issued under the replaced MDD/AIMDD.

- Significant Design Changes - Intended Use/Indications for Use

MDCG 2020-03 Guidance defines in detail what can be considered significant changes or not.

It is important to mention that QMS documentation shall be aligned with these requirements and the change control procedure shall include the requirements mentioned within this guidance document.

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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MDR Regulatory Requirements and Key Changes

TOPICS

The Organisation for Professionals in Regulatory Affairs

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