The 2018 revision of ISO 10993-1 aligns closely with the Medical Device Regulation (MDR) to provide clearer and more detailed guidance on compliance requirements for medical devices. This updated standard emphasizes the importance of understanding the chemical and physical nature of the product, which is crucial for ensuring biocompatibility and safety.
This presentation, recorded at our Open House Event in Leuven on 4 March, offers an in-depth look at these revisions and their implications for medical device manufacturers. At the time of recording, there was no indication that the enforcement date of the MDR might be postponed, adding urgency to the need for compliance.
The revised ISO 10993-1 standard provides more explicit instructions on conducting biological evaluations of medical devices within a risk management framework. It stresses the need for comprehensive chemical characterization and a thorough understanding of the physical properties of materials used in medical devices. This detailed focus helps manufacturers identify potential risks and ensure that their products are safe for patient use.
The presentation will delve into key changes introduced in the 2018 revision, including enhanced requirements for chemical and physical testing. It will explain how these changes support the MDR’s goals of improving device safety and efficacy. Attendees will gain insights into the practical steps needed to comply with both ISO 10993-1 and MDR, ensuring their products meet the stringent regulatory standards.
By watching this presentation, participants will understand the critical aspects of the revised standard and how to implement these requirements effectively. This knowledge is essential for navigating the regulatory landscape and achieving successful product approvals.