The entries on this page include publications and presentations developed as part of the MGMC initiative to develop harmonized standards for medical-grade materials, as well as pertinent materials from other organizations.
Guidelines for the Classification of Medical-Grade Polymers Used in Nonimplantable Applications (2024). This document follows the path of recent publications by the Association of German Engineers (VDI) and the North America Medical-Grade Materials Consortium (MGMC) to develop a guideline for defining what constitutes a medical-grade material. The purpose of this document is to formalize a review of the three previous publications and create a soft guideline for immediate adoption.
- Guidelines for the Classification of Medical-Grade Polymers Used in Nonimplantable Applications. Cincinnati: North America Medical-Grade Materials Consortium, 2024. Available Here.
- Richtlinien für die Klassifikation von “medical-grade” Polymeren, die bei nicht-implantierbaren Anwendungen zum Einsatz kommen. Cincinnati: North America Medical-Grade Materials Consortium, 2024. German Translation Available Here.
Guidelines for Medical Grade Material Definition; Part 2: Regulatory Compliance, Shipping and Logistics, End-User Disinfection, and Customer Expectations (2023). This is the second installment of a white paper series compiled by the North America Medical-Grade Materials Consortium (MGMC).
This paper continues the discussion by looking at how elements of regulatory compliance; shipping and logistics; end-user cleaning, disinfection, and sterilization; and customer expectations may interact to help shape usable definitions of medical-grade materials.
- Guidelines for Medical Grade Definition, Part 2: Regulatory Compliance, Shipping and Logistics, End-User Disinfection, and Customer Expectations. Cincinnati: North America Medical-Grade Materials Consortium, 2023. Available Here.
- Richtlinien für die Definition von „medical-grade Material,“ Teil 2: Einhaltung gesetzlicher Vorschriften, Versand und Logistik, Endnutzer-Desinfektion und Kundenerwartungen. Cincinnati: North America Medical-Grade Materials Consortium, 2024. German Translation Available Here.
MD&M Session Highlight: Experts Present Next Steps for Harmonized Medical-Grade Materials [online]. Medical Design Briefs, 7 February 2023. Available Here.
Guidelines for Defining Medical-Grade Materials; Part 1: What Is a Medical-Grade Material? (rev ed, 2024)
This is the first installment of a white paper series compiled by the North America Medical-Grade Materials Consortium (MGMC). Originally written in 2019, the version presented here—and its companion German translation—have been newly revised for 2024.
This paper describes the genesis and evolution of an ongoing initiative to establish a comprehensive definition of medical-grade materials, with an emphasis on polymers used in four broad application categories:
- Medical-grade materials
- Locked-down grade materials
- Pharmaceutical packaging materials
- Skin-contact grade materials
For each of these categories, the paper defines the properties and testing requirements for the types of ingredients, manufacturing, and quality assurance activities that would permit a material to be classified within a particular category.
- Guidelines for Defining Medical-Grade Materials; Part 1: What Is a Medical-Grade Material? (rev ed). Cincinnati: Ethicon, 2024. Available Here.
- Richtlinien für die Definition von medical-grade Materialien; Teil 1: Was ist ein medical-grade Material? (rev Ausg). Cincinnati: Ethicon, 2024. German Translation Available Here.