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Labeling Changes & Challenges to Comply with EU MDR

The introduction of European Medical Device Regulation (EUMDR 2017/745) gives great importance to the end user to assist with the safe and proper use of a medical device(s). The EU MDR and other UDI-type of regulations is causing more and more medical device companies to revisit their labeling processes. EU MDR introduces additional information that needs to be included on labels, forcing organizations to re-design the label templates that make room for data not previously part of the labeling system. According to EU MDR ….. “The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.” Harmonized Symbols Under the EU MDR addition of symbols is a new field on their labeling documents. The usage of symbols helps to manufacturer and also avoids having to provide the information in multiple languages in labeling documents. The MDR regulations allow that the information supplied by the manufacturer can be provided as internationally recognized symbols (ISO 15223). CE Marking The letters “CE” are the abbreviation of French phrase “Conformité Européene” which literally means “European Conformity” with health, safety, and environmental protection standards for products sold within the European Economic Area. The term initially used was “EC Mark” and it was officially replaced by “CE Marking” in the Directive 93/68/EEC in 1993. “CE Marking” is now used in all EU official documents. Warnings & precautions on label This change will probably have the biggest impact. MDR mandates all warnings relating information to a device must be printed on the label. Regulation says information can be kept to a minimum – with more detail in the IFU. UDI system The Unique Device Identification (UDI) is a system that unambiguously identifies a medical device through its distribution and use within the healthcare supply chain. UDI is comprised of two parts i.e., Device identifier and Production identifier.
  • A Device Identifier (DI): a mandatory, fixed portion of a UDI that identifies the specific Product Number of a device and the labeler of that device; for products, this is the GS1 Global Trade Item Number (GTIN); and
  • A Production Identifier (PI): a conditional, variable portion of a UDI that identifies one or more of the data elements (e.g., lot, batch, serial number, etc) when included on the label of the device:
EU MDR requires UDI label be directly attached to a medical device or to its packaging. So all the labels must include PI (GTIN) and DI components as textual and barcoded content.