MDCG 2024-13 and MDCG 2022-5 Rev 1 released
MDCG 2024-13 and MDCG 2022-5 Rev 1 released
Wednesday, 06 November 2024
Kirsten Van Garsse, Director AR Services and Manager IVD - RA and Anne Paulussen Senior Consultant IVD - RA
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On October 29th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance (MDCG 2024-13) on the regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices. In addition the MDCG released its first revision (MDCG 2022-5 Rev 1) of the guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.
MDCG 2024-13
MDCG 2024-13 includes detailed information on the regulatory status of ethylene oxide (EtO) for the sterilisation of single-use medical devices during the manufacturing process which has been discussed in relation to the Review Programme under Regulation (EU) 528/2012 on biocidal products (BPR).
Ethylene oxide (EtO) used to sterilize medical devices and IVDs during manufacturing, falls under MDR/IVDR regulations, which cover sterilization processes, but EtO itself is not classified as a medical device. Consequently, EtO is exempt from the Biocidal Products Regulation (BPR), per Article 2(2)(b) since it does not apply in case of biocidal products or treated articles falling within the scope of the MDR or IVDR. For health institutions, EtO used for pre-use or post-use device sterilization is considered a medical device accessory, keeping it regulated under MDR while remaining outside BPR scope.
MDCG 2022-5 Rev 1
The MDCG released its first revision on the guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices. The update covers the inclusion of an additional example of medical devices.
What does it mean to you?
MDCG 2024-13 is crucial for IVD/MD manufacturers that use ethylene oxide during their manufacturing process.
MDCG 2022-5 contains some very valuable insights when you are faced with a product of which you must determine if it falls under the MDR or the Medicinal Product Directive. It can also provide useful information for combination devices, that thus consist of a medical device and medicinal product part.
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