MDCG 2022-5 Clarifies Sterilization Products for Medical Devices

The Medical Device Coordination Group (MDCG) has issued an important update to its guidance on the borderline between medical devices and medicinal products, under the MDR. The guidance document, known as MDCG 2022-5, is intended to clarify the categorization and regulatory requirements for products used in conjunction with medical devices. This update specifically addresses products used in the cleaning, disinfection, or sterilization of medical devices.

How Does MDCG 2022-5 Clarify Sterilization in Device Manufacturing?

In Section 1.2.6.1 of the guidance, a new clarification has been added regarding products meant for sterilization. It specifies that products, such as ethylene oxide used for sterilizing endoscopes, are applicable not only for end-user sterilization but also for sterilization during the manufacturing process of medical devices. This change helps manufacturers better understand regulatory boundaries when integrating sterilization products into the production process, ensuring they comply with MDR requirements.

This updated guidance provides enhanced clarity for manufacturers, healthcare providers, and regulatory professionals, supporting them in the classification and application of products that may fall on the borderline between medical devices and medicinal products. By doing so, the MDCG aims to improve safety, regulatory compliance, and consistency across the industry.

For more details, the full document is available in the MDCG 2022-5 guidance PDF.

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If you are a medical device or IVD manufacturer with questions about the new MDCG 2022-5 update clarifying sterilization products for medical devices, or if you need assistance navigating compliance requirements, please contact us. We’re here to help you stay informed and compliant with the latest regulatory updates in the medical device industry.

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