MDCG clarifies how ethylene oxide is regulated under MDR, IVDR

The European Commission’s Medical Device Coordination Group (MDCG) has issued guidance on how the medtech industry should handle ethylene oxide (EtO) under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The sterilizing gas is widely used by the medtech industry to clean products, largely due to its ability to penetrate small spaces.

On 29 October, MDCG published the guidance, which refers to specific sections of the MDR and IVDR when using EtO and considering international standards. The group noted that the carcinogenic gas is used to sterilize medical devices, in vitro diagnostics, and combination products, as well as reusable medical devices on a much smaller scale with cartridges.

“EtO is a substance that is used in the manufacturing process of many medical devices and IVDs which are placed on the market in a sterile condition,” said MDCG. “As part of its Quality Management System (QMS) pursuant to Article 10(9) MDR and Article 10(8) IVDR, the relevant medical device manufacturers must address, among other matters, the sterilization process and its validation, which is further specified e.g. in the harmonized standard EN ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes.”

MDCG lists several other parts of MDR and IVDR that detail general safety and performance requirements related to device sterilization that can be met with certain international standards. The group also lists technical documentation, qualification requirements of notified bodies, and conformity assessment procedures underlined in the regulations.

“As a consequence, EtO used for sterilization during the manufacturing of medical devices, and IVDs is used for a process that falls within the regulatory obligations imposed by the MDR and IVDR,” said MDCG. “That means that this use of EtO is in scope of the MDR and IVDR even though EtO does not itself fall under the definitions of medical device or accessory for a medical device if used during the manufacturing process.”

The guidance adds that EtO is often used by health institutions to sterilize reusable devices before and after use. In such cases, the EtO cartridges used to sterilize the products are considered medical devices and fall within the scope of MDR requirements.

Alongside the guidance, MDCG also published revised guidance on the borderline between medical devices and medicinal products under EU law. It notes that sterilization agents such as EtO fall under MDR unless they are considered multi-purpose products not specifically intended for medical device sterilization.

"Multipurpose disinfectants or sterilization agents which are not specifically intended by their manufacturer for the disinfection or sterilization of medical devices are not covered by the MDR; they are covered by the Regulation (EU) 528/2012 on biocidal products," said MDCG.

On the other side of the Atlantic, EtO has been a major topic in recent years for the medtech industry as the US Environmental Protection Agency (EPA) has instituted several rules that limit the use of the gas to prevent potential exposure to communities near sterilization facilities. The US Food and Drug Administration has been holding periodic town hall meetings to help companies ween off EtO where possible and has raised concerns about potential device shortages caused by the rules. (RELATED: FDA concerned about potential device shortages due to new EtO limits, Regulatory Focus, 20 May 2024)

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