A unique device identification (UDI) system for medical devices is essential in identifying them wherever they are in the healthcare supply chain. In fact, the United States Food and Drug Administration (FDA), the European Commission and other regulators have made patient safety a strategic priority by developing legislation for UDI. And in addition, manufacturers also need to comply with the …
Medical device community shares insight on label management tools
Last week at the Q1 Productions 8th Annual Medical Device & Diagnostic Labeling Conference, delegates from medical device manufacturers, notified bodies, legal firms and solution providers came together to discuss the latest developments in medical device labeling including integration of new labeling requirements like EU MDR / IVDR, achieving UDI barcode quality, direct marking challenges and label creation and delivery …
A recap of the Medical Device Packaging & Labeling Summit
Last week, medical device manufacturers from across the U.S. came together to discuss the constantly changing world of labeling at Q1 Productions’ 6th Semi-Annual Medical Device Packaging and Labeling Summit. While abiding by FDA labeling requirements presents ongoing challenges for these companies, topics like localization and translation also dominated much of the agenda. This group is always candid and open …
The EU MDR and IVDR have been approved. So, what’s next?
On April 5th Europe finally adopted the MDR and IVDR after a vote at the European Parliament. This was the last step in the European Union’s long process of overhauling medical device and IVD regulation. The new regulations on medical and in-vitro diagnostic medical devices will help to ensure that all medical devices – from heart valves to sticking plasters …
European Medical Device Directives – How a small-medium sized medical device company responded to the new regulations
The medical device directives are currently being revised by the EU’s institutions in a process that began in 2008. This revision has the following objectives: To ensure a consistently high level of health and safety protection for EU citizens using these products To maintain the free and fair trade of the products throughout the EU To adapt legislation to the …
UDI labeling: common mistakes and best practices
There’s no doubt that UDI is a hot topic among medical device manufacturers. They are currently under pressure to comply with the FDA’s UDI requirements. Europe plans to introduce similar rules that companies will need to adhere to in the next three to four years. Other countries like Brazil, Turkey and China are introducing their own rules. It’s clear that …
Europe is closely watching UDI
The conference was a UDI-dedicated networking and learning meeting for device manufacturers and healthcare providers. The focus was on how they can support each other to benefit the patients. I recently attended and presented at the UDIs & Traceability for Medical Devices Forum in Munich. A prominent theme at the event was technology and how compliance to UDI and other …