MDCG: Ethylene Oxide in medical devices and Borderline Classification

In October 2024, the MDCG published two documents: one on the regulatory status of ethylene oxide (EtO) used for the sterilisation of medical devices, and the other providing guidance on the borderline demarcation between medical devices and medicinal products.

Key takes from the Regulatory status of EtO

In this publication, the MDCG addresses the status of EtO under the EU Medical Device Regulation (MDR). Ethylene oxide is a substance used in the manufacturing process for many medical devices and IVDs that are marketed in a sterile condition. This material is in the scope of the MDR and IVDR even though it does not itself fall under the definition of a medical device or accessory for a medical device if used during the manufacturing process.

In particular, medical device manufacturers using the EtO must address:

  1. As part of their Quality Management System (QMS), sterilisation process and its validation,
  2. General safety and performance requirements in Annex I MDR/IVDR,
  3. Technical documentation described in Annex II MDR/IVDR,
  4. Qualification requirements of notified body personnel laid down in Annex VII (sections 3.2.1 and 3.2.5), and
  5. Conformity assessment procedures laid down in Annex IX and XI MDR/IVDR.

Key takeaways from the Guidance on the borderline between medical devices and medicinal products

This guidance provides insight into products that may be classified as either medical devices or medicinal products, offering a general discussion on the borderline between the two legislations, along with relevant definitions and examples.

In the most recent revision of the Guidance, the MDCG modifies Section 1.2.6.1 (examples of medical devices) by adding a new example of medical device: products specifically intended for the cleaning, disinfection or sterilisation of medical devices.

With this, the MDCG confirms that these products are regulated as medical devices under MDR and not as medicinal products.

 

Do you have any questions regarding the classification of your devices? Find all the documents in our dedicated Library on classification or contact us directly!

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