UDI Regulation INEL Solutions

19.04.2021

Unique Device Identification (UDI) is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard.

Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

INEL as the centric European turnkey supplier of devices for serialization, aggregation, labeling and diverse end of line solutions can provide comprehensive solutions that are compliant with UDI Regulation.

'Medical device' means any instrument, apparatus, device, software, implant, reagent, material or other object which the manufacturer intends to use alone or in combination with humans for one or more of the specific medical purposes.

We provide solutions operating on a custom made machines which will facilitate easier traceability of medical devices and allow authorities abetter monitoring with effective reports. INEL Solutions will also help to reduce medical errors and to fight against falsified devices. Our solution can also improve purchasing, waste disposal and stock-management at health institutions and other operators.

Here are some examples of certain medical product which also falls under the directive:
contact lenses, facial fillers, equipment for liposuction, equipment emitting high intensity electromagnetic radiation, transcranial brain stimulation equipment etc.

We are proud to announce that INEL is a gold sponsor of GS1 Slovenia and JAZMP specialist seminar: Marking medical devices according UDI (Unique device identification). Online event will take place on Tuesday, 20th of April 2021 at 10:00. For more information about the seminar click here.

Source: https://ec.europa.eu/health/sites/health/files/md_topics-interest/docs/md_faq_udi_en.pdf