The PMDAC has created this Change and Certification Resource Guide to assist companies in their evaluation and management of changes to polymeric materials that are used in the production of medical devices. Materials used in medical device applications are produced under carefully controlled manufacturing conditions, and these materials must meet a range of requirements. This guide incorporates an extensive list of requirements that apply to these materials, which cover the critical elements that must be controlled when making a change.
The guide assesses a comprehensive range of changes, including those to chemical components, production processes, product certifications, quality agreements, and product specifications. The guide then uses an assessment methodology to identify the specific requirements that would apply to proposed changes, and also to identify the appropriate actions that would be required.
This guide was designed as a resource tool for companies involved in the medical device business to assist with understanding and managing the requirements of a change, and which in turn may help in defining the scope of the attendant change management project. In this regard the guide will help identify the requirements, and the associated impact of specific changes. It also allows the user to perform a comparative assessment by reviewing the impacts of several change options in order to identify the best one to implement.
The intention of this guide is to unite industry under commonalities and best practices for product and change certification, thereby reducing the time required for proposed and often necessary material or process changes. The resource guide helps with making change management processes and decision making more efficient and, ultimately, it plays a role in making the medical supply chain an easier to navigate domain when it comes to changes.
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Suppliers of basic chemicals provide the fundamental chemicals that are used by companies to manufacture the raw materials used in making medical devices.
Manufacturer of a polymeric product, including a base resin with any additives or adjuvants, marketed by its performance attributes. The polymer product requires one or more additional manufacturing steps in order to be used in medical devices, and may have end uses in addition to medical devices.
Raw materials are additives and colorants, which are chemical components that do end up in the final product. These chemicals may be provided to the processor, and also to master batch producers.
Processors make articles, such as medical devices, using a formulation based on resin from the resin producer, additives and colorants from the formulators, and even basic chemicals. The article is not fundamentally changed by their customers but may be packaged for sale as is or used with other articles to complete assembly of a medical device or kit before sale.
This publication, Change and Certification of Materials in Medical Devices, has been prepared by the Plastics Industry Association (PLASTICS) as a service to the plastics industry and the broader medical device supply chain. It is intended for use as a general reference tool for communicating and documenting changes to materials used in medical devices for all parties in the supply chain. It is not intended to and does not establish any industry standards or duty of care. This publication does not take into account such factors such as the relationship with the supplier or customer as well as the use and functionality of a material. It is not intended to provide specific advice, legal or otherwise, on a specific product. Any examples, citations, or references included herein should not be considered an appropriate model without further consideration to the regulatory status of your specific product. Readers should consult with their own legal and technical advisors, their suppliers, and other appropriate sources, that will have relevant information about known and reasonably foreseeable health and safety risks for their proprietary products and processes. Readers are solely responsible for and assume the risk arising from the use of the information provided in this publication. PLASTICS, its members, contributors, agents, and attorneys make no warranty, express or implied, as to the accuracy, completeness, or suitability of the information provided herein, and do not assume any responsibility for the user’s compliance with applicable laws and regulations.