After an initial call to action presented at the 2017 Medical Design & Manufacturing Conference and Exposition in New York City, Ethicon convened the first Medical-Grade Materials Consortium Mini-Conference on 8 August 2019, in Cincinnati.
The conference established that the scope and ultimate goal of the MGMC initiative would focus on developing 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
It was determined that nonmedical and implant-grade materials would not be included within the scope of the initiative.
Establishing a uniform set of criteria for defining these materials is an important step in helping manufacturers and regulators ensure that the materials used in manufacturing medical products meet their agreed-upon specifications. When fully harmonized, such criteria will simplify the selection and use of appropriate materials across the globe.
MGMC Partners
