The EU Medical Device Regulation (MDR) 2017/745 of the European Union obliges producers, distributors, importers and EU representatives of medical devices or their packaging to clearly mark their products as of May 26, 2021. Medical devices will thus be completely traceable from the manufacturer to the user and guarantee the patient safety required by the EU.
The standards and regulations passed in accordance with the Medical Device Regulation are equally binding for all players. To this end, the product identification required for the medical device is issued by one of the four allocation authorities - GS1, HIBCC, ICCBBA and Informationsstelle für Arzneispezialitäten.
From May 2022, all medical devices will be stored bit-by-bit in the EU-wide EUDAMED database with their master data and the "Unique Device Identification" (UDI).
The product identification consists of two components:
Medical devices are categorized and classified into risk classes, which are defined by the intended purpose in terms of the place and duration of use of the product.
There are e.g. products for single use or reusable medical devices, implants or others like software and devices.
The resulting risk classes then also specify the implementation deadlines in legislation.
The product identification must be applied either directly on the product, on primary packaging or on all higher packaging levels. According to the Medical Device Regulation the direct marking must be applied by ink, laser or label.
In addition, the code must be easily accessible and readable both in the warehouse and when the product is in use - and this throughout the entire life of the product.
The marking is always in human readable text and as a machine readable code. 1D barcodes or 2D matrix codes can be marked on the medical devices, depending on the available area for direct marking.
Depending on the medical device and its properties, there is a very large variety of possible markings.
REA JET High Resolution Inkjet Printers or Laser Systems are ideal for direct marking on the product or the packaging.
REA JET HR: With priners from the product family High Resolution (HR), marking can be done at high speed and high print quality directly on the product or its packaging. By selecting a suitable ink, it is possible to print directly on paper, plastic or metal.
REA JET Laser Systems: The Laser Marking Systems mark directly on paper, plastic, ceramics or metallic surfaces such as aluminum without the use of consumables. The selection of the laser light source and laser optics depends on the material of the medical devices in question.
Labeling Technology Systems from REA LABEL are suitable wherever direct marking on the product or the outer packaging is not possible with the contact-free coding and marking systems from REA JET. Instead of direct marking, a label is applied to the medical product or the outer packaging.
To ensure that the codes are read error-free with a high first-pass reading rate and that the standards of the Medical Device Regulation are met, the code verification systems REA VERIFIER are used.