Combining selected paper and film face materials with the new RPMD (Raflatac Permanent Medical Device) adhesive ensures excellent adhesion with a tight mandrel hold on glass and plastic, as well as sterilization resistance and migration safety – both common requirements in medical device and healthcare labelling.
The RPMD adhesive range includes labelling solutions for drug/device combination products like insulin pens, auto-injectors, and inhalers, as well as blood donation labelling, sterilization pouches for medical devices, and infusion bags and bottles.
These materials are also compliant with the EU Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) published in May 2017. The Medical Device Directive includes the adoption of a Unique Device Identification (UDI) system to mark and identify medical devices in the healthcare supply chain, with a 2020 implementation deadline.
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. A UDI consists of a device identifier (DI) and product identifier (PI), with the PI data varying according to the type of device and the manufacturer’s current practice. It can be likened to the system used by automotive manufacturers to identify individual components, for example in the event of a safety issue leading to a product recall.
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