UPM Raflatac has further expanded its range of guaranteed, globally available, and compliant pharmaceutical and healthcare label materials for the medical device and healthcare industries.
Today there are over 500,000 types of medical and in vitro diagnostic medical devices available in the EU, with a medical device meaning anything from a contact lens or sticking plaster to an x-ray machine or hip replacement component. In vitro diagnostic medical devices include things like HIV blood tests, pregnancy tests, and blood sugar monitoring systems for diabetics.
The new RPMD (Raflatac Permanent Medical Device) adhesive range includes labeling solutions for drug/device combination products like insulin pens, auto-injectors, and inhalers, as well as blood donation labeling, sterilization pouches for medical devices, and infusion bags and bottles. Combining selected paper and film face materials with an RPMD 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 labeling.
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.
“With our expanded offering for medical device and healthcare applications, including the RPMD adhesive and a selection of FSC and PEFC certified paper faces for pharmaceutical use, we can continue to address the needs of all our customers. These innovative solutions are ideal for the combination product market, which is growing quickly as treatment continues to move away from the hospital and out into the field and the home,” explains Markku Pietarinen, Manager, Business Segments & Pharma, Specials EMEIA, UPM Raflatac.