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Sterile Barrier System in MDR and IVDR

With the transition from MDD to MDR and IVDD to IVDR, manufacturers of medical devices face a number of challenges. One of the most dificult challenges is the sterile barrier system (SBS), which is designed to ensure and maintain the sterility of the device throughout the supply chain, usually up to the operating room. With some exaggeration, the SBS can be considered an accessory or directly integral part of the medical device.

The purpose of this one-pager is to introduce manufacturers to new versions of the technical standards used to meet the requirements of MDR/IVDR.

Sterile Barrier System
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