Brief Report
Version 1
Preserved in Portico This version is not peer-reviewed
Viable Biological Materials or Organisms in Regulation (EU) 2017/745 on Medical Devices
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Version 1
: Received: 5 July 2024 / Approved: 9 July 2024 / Online: 9 July 2024 (13:10:12 CEST)
How to cite: Morán, J.; Kilasoniya, A. Viable Biological Materials or Organisms in Regulation (EU) 2017/745 on Medical Devices. Preprints 2024, 2024070761. https://doi.org/10.20944/preprints202407.0761.v1 Morán, J.; Kilasoniya, A. Viable Biological Materials or Organisms in Regulation (EU) 2017/745 on Medical Devices. Preprints 2024, 2024070761. https://doi.org/10.20944/preprints202407.0761.v1
Abstract
Regulation (EU) 2017/745, addresses medical devices and clarifies the scope regarding products containing viable biological materials or organisms. This regulation excludes products containing viable cells or tissues of human or animal origin, as well as those containing viable biological materials or organisms of other origins intended to achieve or support the intended purpose of the products. The term "inviable" is defined as incapable of metabolism or multiplication. The regulation mandates that products manufactured using non-viable biological substances must ensure the highest safety standards, including validated methods of elimination or inactivation of transmissible agents during manufacturing. Several Directives and Regulations provide context for the term "viable" in medical devices, emphasizing the device's ability to perform effectively and safely. Notified Bodies in the EU have interpreted that thermally inactivated microorganisms in a product do not classify it as a medical device under Regulation 2017/745. To address this, it is crucial to differentiate between the inactivation of microorganisms and the viability of their metabolites. Demonstrating the inviability of microorganisms through rigorous testing and evidence is essential for regulatory compliance and safe use in medical products. Clarifying these points and providing necessary evidence can establish that inactivated microorganisms are inviable and meet the requirements for use in medical products.
Keywords
viable biological materials; Regulation (EU) 2017/745; medical devices; microorganism inviability; regulatory compliance
Subject
Medicine and Pharmacology, Complementary and Alternative Medicine
Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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