Unique Device Identification - marking of medical devices
The EU Medical Device Regulation (MDR) 2017/745 requires manufacturers, distributors, importers and EU authorized representatives of medical devices or their packaging to be clearly marked from 26 May 2021. In medical technology, medical devices will therefore be fully traceable from the manufacturer to the user and guarantee the patient safety required by the EU.
Unique Device Identification (UDI)
The EU Medical Device Regulation (MDR) 2017/745 requires manufacturers, distributors, importers and EU authorized representatives of medical devices or their packaging to be clearly marked from 26 May 2021. In medical technology, medical devices will therefore be fully traceable from the manufacturer to the user and guarantee the patient safety required by the EU.
The standards and regulations adopted in accordance with the Medical Device Regulation are equally binding for all stakeholders. To this end, the product identification required for the medical device is assigned by one of the four allocation bodies - GS1, HIBCC, ICCBBA and the Information Center for Proprietary Medicinal Products.
From May 2022, all medical devices will be stored with their master data and the unique device identification (UDI) in the EU-wide EUDAMED database.
The product identification consists of two components
- Device Identifier (DI): a static code with approx. 20 pieces of data for manufacturer and product identification
- Production Identifier (PI): variable data used for traceability, such as batch number, expiry date or serial number
Implementation deadlines
Mandatory labeling for risk classes
Where does the UDI marking have to be applied?
Direct marking by ink, laser or label
The product identification has to 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 has to be applied by ink, laser or label. In addition, the code has to be easily accessible and readable both in the warehouse and when the product is in use - for the entire product life.
UDI Podcast from the Johner Institute
Listen to the podcast from the Johner Institute on the UDI topic with Prof. D. Christian Johner and Mr. Wilfried Weigelt.
The marking is always in plain text and as a machine-readable code. Depending on the surface available for direct marking, 1D Codes or 2D Matrix Codes can be marked on the medical devices.
Depending on the medical device and its properties, there is a very wide range of possible markings. REA VERIFIER's code verification systems are used 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.
High-resolution inkjet printers based on HP cartridges
REA JET HR coding and marking systems based on HP cartridges are ideal for high-resolution 2D Codes, brand logos or other markings in high quality - and at high speeds. Products and packaging can be marked with a print height of 12.7 mm per print head - several print heads can be cascaded for greater print heights. High first-pass reading rates are therefore no problem at the point of sale.
REA LASER CL
REA LASER CL Laser Systems mark packaging made of organic materials permanently, highly precisely and individually. The laser systems are consumable-free. High first-pass reading rates are also guaranteed.
REA LASER FL
REA LASER FL Laser Systems mark plastic packaging contact-free, precisely and individually. Fiber laser marking is permanently durable and ideal for harder metals such as stainless steel and titanium as well as for plastics and thin foils. The laser systems are consumable-free. High first-pass reading rates at the point of sale are also guaranteed here.
Labeling technology
Wherever direct marking with Inkjet Printers or laser marking systems is not an option, labeling solutions are the answer.
REA LABEL offers suitable solutions for this purpose, from simple tabletop label printers to complex labeling systems for all applications.
Code checking systems
Code verification systems from REA VERIFIER are used to ensure that markings and codes are error-free and comply with international standards. In this way, each marking receives an acceptance test report.
REA offers a complete product portfolio and code know-how for the implementation of this task. Get in touch with us.
REA is your partner
Advice and training
- REA advises and trains you in UDI matters
- Procurement of competent partners for data management
- Suitability and use of coding and marking technologies
- Suitability and use of verification systems for compliance with code quality specifications
