Permanent identification for your medical devices.
Medical machines and devices must be identified in accordance with various laws and guidelines.
In addition, new guidelines for medical devices and aids will come into force on 26 May 2021: the European Medical Device Regulation (MDR).
Part of these guidelines is the introduction of rules on product identification, applicable to all manufacturers, importers and distributors of medical equipment and devices.
In conjunction with the various classifications, product labels must also meet a number of requirements, and Rebo has always the right solution.
Medical Device Regulation (MDR) labels
Medical Device Regulation (MDR) labels are used on medical devices that are stored and used in various conditions, such as sterile environments, damp areas or places with extreme temperatures. Our MDR labels are resistant to disinfectants and sterilisation processes. They guarantee long-term legibility without fading or peeling.
MDR labels are an important part of the regulations and help to ensure the safety and transparency of medical devices in the EU. Important requirements for MDR labels are:
- Unique identification with a traceable code;
- CE-marking;
- Product information (description, model number and serial number);
- Manufacturer information;
- Sterilisation and storage information;
- Warning symbols and instructions;
- Language requirements: in the official language of the country of sale.
Our MDR labels for your printer are essential in various sectors. The labels can be used in healthcare, laboratories, pharmaceutical companies and medical manufacturers. With our MDR labels, you comply with European regulations and your products remain easily traceable within the supply chain.
A fitting solution
In particular, the new MDR requires labels to be indelible. In addition, labels should be temper proof and permanently attached to the equipment, including on the difficult-to-adhere substrates with a low surface tension. These requirements can be tested by external authorised parties.
In addition, there are other factors that may be important for the use of the product such as resistance to chemicals, extreme freezing temperatures or extreme heat & autoclave applications.
(For more information on the MDR regulations click here.)
MDR labels in-house
Save costs and reduce delivery times without being tied to large minimum order quantities. With the software, you can easily design and print your own MDR labels, including your company logo, scannable (QR) codes that link to product pages or manuals, and all the necessary MDR information.
Thanks to the option of adding input fields and database links, employees can work with fixed templates. This means they only need to select or enter the relevant data, after which uniform and compliant labels can be printed immediately.
Requirements for MDR labels
The MDR labels for your printer are made from durable materials and meet strict requirements, ensuring they remain legible and reliable for a long time, even under challenging conditions such as extreme temperatures and exposure to moisture and chemical influences.
Order MDR labels for your own printer and retain complete control over your stock and production. The flexibility of in-house label production also allows you to respond quickly to changes in regulations, product information or market requirements without having to rely on external suppliers.
Countless applications with one system
A great added value of our systems is that you can use them not for just one purpose but for all your professional labels and markings such as:
• Electronic components
• Wire marking and cable coding
• Instruction and safety labels
• Pipe marking (ISO 20560)
• Inspection and calibration labels
• Logistical labels, Floor marking and more!
A Rebo SMS label printer ensures that you can meet all your labelling needs with just one system, in an extremely user-friendly and efficient way.
Print MDR labels with your own printer
MDR labels not only help to correctly identify and trace medical devices, but also contribute to compliance with strict regulations in the EU and beyond. Clear and durable labelling minimises the risk of medical devices being mixed up. The Unique Device Identification (UDI) makes it possible to track every device from production to use by the patient.
Thanks to durable and long-lasting labels, crucial product information remains available at all times, even under sterile or extreme conditions. By complying with international labelling standards, your labels ensure that medical devices can be used in different countries without any problems.
All important product information, such as batch number, production date and expiry date, is immediately available via a scannable barcode or QR code. By implementing MDR labels correctly, you enhance the reliability and safety of medical devices within the supply chain. Would you like to know more about how our MDR labels can be used with your own printer? Please contact us for advice!
