Moving from MDD to MDR – impact on packaging - 25 August 2017

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The SBA developed a Position Paper which compares the ‘General Safety and Performance Requirements (SPRs)’ of the MDR that are relevant for sterile barrier systems (SBS) with the ‘Essential Requirements (ER)’ of the MDD. The Position Paper summarises key changes regarding sterile packaging and considerations on recommended changes to standards and represents the views of the Sterile Barrier Association based on member’s feedback.

The purpose is for generating a general discussion and contributing to standardisation processes. It shall however not substitute or bypass the standard development process of CEN or ISO.

Download the Position Paper here


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