Unique Device Identification requirements could be driving the need for new labeling solutions.
“Based on UDI coming in with needs for traceability, more information is needed to bring out to the different levels in the packaging of medical devices,” Markku Pietarinen, Manager, Business Segments & Pharma, Specials EMEIA, UPM Raflatac, tells MD+DI. “New materials are needed to comply with the needs for label materials that can be easily printed, converted for the use in the medical device industry packaging process, and also to label the device itself.”
UDI has already emerged in the United States, and now rules are evolving in the European Union. "In April 2017, the EU Commission formally adopted two new regulations on medical devices and in vitro diagnostic medical devices. One of the main regulatory updates is the implementation of a UDI system that provides a globally harmonized and consistent approach for the marking and identification of medical devices," Pietarinen explained in a news release. "A UDI is a code printed on a label affixed to a device or its packaging, or even directly on the device itself, in both plain text and machine-readable format. All medical devices available in the EU must comply with the new regulations by April 2020, with the deadline for in vitro diagnostic devices falling two years later, in 2022."
To help medical device companies with such expectations, UPM Raflatac will launch RPMD (Raflatac Permanent Medical Device) pressure-sensitive adhesive label stock materials for labeling medical devices. UPM Raflatac will be highlighting the launch at the upcoming CPhl Innopack exhibition October 24-26, 2017, in Frankfurt, Germany, in Hall 4.2, Stand 42J50.
The new materials are specially designed for a range of medical devices, including sterilization wraps and bags, infusion bags and bottles, drug-device combinations like pens, auto-injectors and inhalers, and blood donation labeling. “RPMD (Raflatac Permanent Medical Device) pressure sensitive adhesive label stock materials are able to tolerate all commonly used sterilization methods like gamma, EtO, e-beam, and steam autoclaving,” explains Pietarinen. “Our new RPMD adhesive have good adhesion profile to various surfaces and container shapes and sizes with large operating window for various storage conditions.”
UPM Raflatac will also showcase its recent pharmaceutical labeling solutions for compliance with the Falsified Medicines Directive (2011/62/EU) regarding packaging for prescription drugs and high-risk, over-the-counter medicines. UPM Raflatac’s RP62 EU adhesive supplied with tamper-verification products creates a “cardboard tear” on typically used cardboard cartons carrying a water-based varnish, the company reports in the news release.