Medical Grade Plastics – what it really is
Medical Grade Plastics (MGP) or polymers, a term lately been found to wander around among medical device suppliers and manufacturers. Read here, what the term really means.
The understanding
There are many different sources and references to whom has coined the term “medical grade plastics”. Likewise, there are as many definitions for the quality and specifics of medical grade polymers. Whatsoever, the meaning and understanding of the term goes into one single direction; to standardize the quality and quality aspects of polymers used in medical devices, in-vitro diagnostics and for pharmaceutical primary packaging systems.
Medical grade plastics suffice the ideology of a quality management system and in the broad understanding, are treated as if it is a medical device or pharmaceutical excipient. However, there is no generally agreed definition nor an international standard established so far. This leads to the question on how manufacturers of polymers and compounds used for medical devices, in-vitro diagnostics and pharmaceutical packaging should specify and control such materials.
The standardization
A first step towards an internationally harmonized standard has been taken by the Association of German Engineers VDI with the published Guideline on Medical Grade Plastics (MGP). The VDI has defined how to control and document the material and the manufacturing process of MGP in its guideline published in July 2019.
The VDI Guideline takes the long-awaited step towards the definition and explanation of the term MGP and covers the following topics:
- Terms
- Abbreviations
- Definition
- Regulatory requirements
- Formulation requirements by means of consistency
- Supply reliability
- Change management
- Packaging, transport and storage
- Supplier agreement
With this, the VDI guideline is very closely aligned on the supplier requirements for medical devices and pharmaceutical packaging materials according to ISO 13485, ISO 15378 and GMP, respectively.
the future
Currently, there are no published initiatives on converting the VDI guideline into an international harmonized standard or adopting it into an existing standard. In analogy to the Pharmaceutical industry and the IPEC-Guide (International Pharmaceutical Excipient Council) on excipients, we could expect to either have an analogous adoption of the VDI guideline or seeing an implementation into an existing, harmonized standard.
How Avanti Europe can help
The Experts of Avanti Europe can support you as a polymer-, compound- or polymer parts manufacturer in establishing the processes and quality management structure to implement the VDI guideline. Even though the VDI guideline is not mandatory, it well establishes a company for the future and provides a competitive advantage.
