The implementation of MDR/IVDR regulations makes it imperative for Original Equipment Manufacturers (OEMs) to have a comprehensive understanding of the substances present in their medical devices. This requirement is echoed in the impending USP regulations, which mandate the use of ‘well-characterized materials’. With the growing list of ‘substances of concern’ and the increasing scrutiny from regulatory bodies, how can manufacturers ensure compliance?
This presentation will address the practical challenges OEMs face in identifying and managing the substances within their devices. The traditional approach of querying suppliers with ‘Does it contain XYZ?’ often leads to unexpected and sometimes incomplete answers. Many OEMs may also lack the in-depth knowledge of plastics materials necessary to navigate these complexities effectively. This raises the question: do manufacturers need to test for every possible substance?
A robust ‘risk management’ strategy begins with understanding the scope of available information and recognizing its limitations. This presentation will explore the steps necessary to develop such a strategy, focusing on practical solutions to obtain the required data. Attendees will learn about the challenges involved in gathering comprehensive information on device materials and how to overcome these obstacles.
The presentation will highlight the role of MedPharmPlast Europe and its extensive expertise in the field. Leveraging the organization’s ‘vertical expertise’ can provide invaluable support to OEMs, drawing on hundreds of years of combined experience in plastics and regulatory compliance. By tapping into this knowledge base, manufacturers can better navigate the regulatory landscape and ensure their products meet all necessary standards.
Participants will gain insights into how to effectively manage the risks associated with unknown substances in their devices. This includes strategies for obtaining reliable information from suppliers, understanding the regulatory expectations, and implementing thorough testing where necessary. The goal is to equip OEMs with the tools and knowledge needed to achieve and maintain compliance with MDR/IVDR and upcoming USP regulations.
By the end of the presentation, attendees will have a clearer understanding of the practical steps required to address these regulatory challenges. They will be better prepared to ensure their devices are compliant, safe, and effective, thereby protecting both their businesses and their end-users.