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Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe.

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Regulation and Guidelines:

New Published: MDCG 2024-13 "Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices"

It addresses two main scenarios: EtO sterilization during the manufacturing process and EtO used by health institutions for sterilizing medical devices. For manufacturing, EtO sterilization falls within the scope of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), subject to quality management systems, safety requirements, and conformity assessment procedures. This use of EtO is excluded from the Biocidal Products Regulation (BPR). When used by health institutions for sterilization before or after device use, EtO cartridges are considered medical devices or accessories under the MDR, also excluding them from BPR scope. The document emphasizes that while EtO use is regulated under MDR/IVDR, EtO itself does not require separate conformity assessments beyond the sterilization process validation.

​Link to document​

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MDCG 2022-5 rev.1 - Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices

What has changed: Update on section 1.2.6.1 - "products specifically intended for the cleaning, disinfection or sterilisation of medical devices"

​Link to document​

What else could be interesting:

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Your Regulatory Globe Team

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