Europe’s Medical Device Regulations are ushering in some new considerations for medical device packaging. For instance, does your packaging take into account the generally acknowledged state of the art? Transportation and storage risks? Final end-user needs at the point use?
Are your validations complete? Does your labeling include all expected symbols and Unique Device Identification? Have you addressed the possibilities for device reuse?
The impact of the EU MDR was addressed in an October 5 Webcast, “Speed Up Your Compliance Process—With Help from DuPont Tyvek.” Thierry Wagner, Regulatory Affairs Director—Europe, Middle East & Africa; and Nicole Kaller, Application & Package Engineering Specialist—Europe, Middle East & Africa, members of the DuPont Tyvek Medical and Pharmaceutical Protection Team, reviewed the new EU MDR/IVDR (Device Regulations and In Vitro Diagnostics Regulations) and explained the impact on sterile packaging.
Wagner recently contributed to the white paper, “Europe’s Emerging Medical Device Regulations and Their Impact on Packaging Decisions.” Says Wagner: “The new MDR introduces a few specific changes to the general safety and performance requirements that have to be met by packaging. There will be new labelling and documentation requirements and more scrutiny by notified bodies. The transition time is short; it is important to start as early as possible.”
Kaller also discussed the full suite of tools available from DuPont to help MDMs accelerate their product regulatory submissions and certifications.
“DuPont’s tools are based on in-depth analysis of industry regulations and MDM requirements," says Kaller. "They help you to find the data and information you need for the validation of sterile barrier systems made with Tyvek and provide valuable design and application guidance."
Kaller also discussed the new Tyvek Technical Reference Guide, which is designed to support MDMs with the regulatory information required for technical documentation. It includes the latest data and information for Transition Tyvek 1073B, Transition Tyvek 1059B, and Tyvek 2FS.
If you are planning to work on a gap analysis for your packaging applications versus the new MDR or you are interested in new Tyvek data, listen in to the now on-demand Webcast and question-and-answer session.
Editor's note: This article has been updated to reflect the now on-demand status of the Webcast.