The Medical Devices Directive (MDD) is changing to EU MDR Medical Device Regulations (MDR) requiring all suppliers of medical devices to keep batch traceability records.
The transition from MDD to the EU MDR has brought about a wave of uncertainty but a promising development in the European medical device industry.
New EU MDR require total lifecycle traceability between all stages of medical device development and post-market activities. Demonstrating traceability throughout the product lifecycle is a revolutionary approach to quality management.
To keep track of devices through every lifecycle stage, a device identifier must be assigned, and all production series will be marked with a production identifier. These tracking measures satisfy the new mandate for Unique Device Identification (UDI), which is entered into the EUDAMED database. Understanding the requirements set out in the MDR and preparing for changes will allow businesses a successful transition.
What is UDI?
To uniquely identify, track and trace individual medical devices through the supply chain, into a patient pathway, the EU has published UDI regulations for medical devices.
These regulations will enhance quality of care, patient safety and business processes, fundamentally improving patient safety and enabling the ability to remove an unsafe or recalled product from harm’s way before it reaches a patient.
What does this mean for you?
As a medical device manufacturer, you will have to apply a unique identification number to each medical device label, its packaging and, in some cases, the device itself. You must then share information about each device with regulatory databases in the EU.
Are you worried about your compliance with Unique Device Identification?
The ConnX Stock Batch Tracking & GS1 Barcode Module lets you get control of your batch-controlled stock, FIFO management and GS1 barcode scanning and printing requirements, all in one module.
Our latest update has added GS1 or EAN-128 barcode scanning to our batch module which allows you to capture the stock code, batch number, expiry date and batch quantity all with a single scan. Saving you time and ensuring data entry errors are a thing of the past.
The ConnX Stock Batch Tracking Module assigns a unique barcode number for every batch / expiry combination and displays this information including location and stock quantity in the real time dashboard.
Our customisable and searchable history function provides all the traceability you need in a simple to use but powerful search tool. Data can be exported in excel or CSV format for sharing or importing into other systems.
Book a no obligation demo to discover more about ConnX Stock’s powerful, but affordable Stock Management software and how it can help your business meet EU MDR Request a demo – ConnX Business Solutions
Read more about EU MDR here The European Union Medical Device Regulation – Regulation (EU) 2017/745 (EU MDR)
