White paper UDI Laser Marking
The implementation of the UDI Directive is mandated for medical device manufacturers. This is not only true for companies that sell their products on the American market, since UDI is also being implemented in the EU and other countries. Medical products must be clearly identified to ensure safe traceability and patient safety. In addition to the marking of packaging and labels, this also applies to the direct marking of high risk products such as implants and instruments. Manufacturers must maintain deadlines and requirements to implement marking systems to apply marking in accordance with UDI requirements and medical standards. In order to implement the demanding labeling, serialization and marking requirements, appropriate technologies are required that allow the codes to be applied and checked with high resolution, permanence with exceptional quality and, if necessary, even in the smallest of spaces.
UDI Requirements, Deadlines, Secure Labeling acc. to FDA and MDR
Implementing UDI concerns almost every medical device manufacturer. In the USA, the FDA (Food and Drug Administration) directive is already in force. For Europe, the implementation of a similar system started in 2021.
Be prepared to comply with the respective programs! Get to know all about the latest deadlines for each class of medical devices. Read about the labeling requirements and find a comparison with pros and cons of all potential marking methods.
- The UDI program: Today in the US, soon in Europe (FDA and MDR)
- UDI codes: Package or direct marking – what has to be marked where?
- Compliance: All deadlines at a glance
- Code examples, code structure and coding system
- GUDID: The central UDI database
- Product identification marking: Challenges and solutions
- Make the right choice: Overview of potential marking methods
Find out if and when your device has to be UDI-compliant. Read all about the latest marking requirements and which method suits your product best. Download the whole document now!