The European Medical Device Regulation (MDR) governs the production and distribution of medical devices and it will be coming into force on 26th May 2021.
The MDR defines the term “medical device” as an “instrument, apparatus, appliance, software, implant, reagent, material, or other article”. This definition covers a broad range of existing devices, and now also includes products used to clean, disinfect, or sterilise medical devices.
To ensure that Serchem Limited labels are fully compliant, a GS1 2D data matrix can be found on all our manufactured products, to facilitate traceability. Each data matrix will contain the product GTIN, expiry date and batch number.
If you are an existing customer and need the product Global Trade Item Number (GTIN) in preparation, please email us at email@example.com