Help for US medical device manufacturers navigating the new European MDR

The MDR takes effect on May 26, 2021 and aims to protect patients from risks posed bymedical products. For manufacturers in the Americas selling such products globally, compliance with international regulations are complex, with requirements varying significantly depending on the intended use, the type of contact with the patient and its duration. 

Trelleborg Healthcare & Medical offers device manufacturers that supply products to Europe a free to download webinar about the upcoming Medical Device Regulation (MDR) and how this specification can be met. 

In the webinar, "Tackle MDR requirements with your supplier's material expertise," Trelleborg and other industry experts explain the material-related requirements of the MDR and how to achieve them. Stefan Bolleininger from the consulting firm be-on-Quality, who knows the potential risks from experience, describes test processes that help achieve MDR compliance. He also explains how important a meaningful risk analysis is and how it is conducted.

Two experts from Trelleborg Healthcare & Medical, Verena Hoerner and Andreas Schmiedel, provide detailed insight into the businesses’ MDR strategy and how it supports medical device manufacturers in meeting MDR material requirements. They guide webinar participants along a pathway of relevant standards, such as ISO 10993 for evaluation of biocompatibility, leading to MDR compliance of the final product.

Following extensive investment in R&D, Trelleborg Healthcare & Medical offers materials specifically developed for medical devices and to meet MDR in various applications. Based on extensive test results it can specify the optimum solution.

Verena Hoerner, Project Development Engineer, says: “Because elastomers are subject to a chemical crosslinking process during manufacturing, simply checking the formulation is not always effective. Therefore, we use detailed extraction tests to assess the suitability of materials for use in specific medical applications. This knowledge is often considerably more informative than checking the individual ingredients. 

“In addition, in order to comply with the MDR's basic principle of maximum patient safety, Trelleborg Healthcare & Medical has implemented a quality management system in accordance with ISO 13485 and takes a risk-based approach to managing its processes.”