medical device labeling

Medical device community shares insight on label management tools

Susan Gosnell Medical Devices Leave a Comment

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 …

UDI compliance

UDI Conference Recap – Getting Labeling Ready for Global Compliance

Susan Gosnell Medical Devices Leave a Comment

Last month, NiceLabel joined members of the FDA and medical device manufacturers from across the country at the 2018 UDI Conference. As with past years, there was a focus on the many benefits of UDI – from reducing medical errors to improving purchasing and supply chain efficiency, however this year there was an added focus on global UDI-related activity. The …

UDI best practice

UDI is going global. Are you ready?

Susan Gosnell Medical Devices Leave a Comment

A recent Emergo blog summarized a workshop held by the European Commission earlier this month where it was revealed that most markets worldwide will have a system for Unique Device Identification (UDI) within the next five years. Based on the presentations by the various medical device authorities, the current thinking is that it will be possible to use a single …

UDI - quality assurance

How UDI compliance can be the key to digitally transforming quality assurance

Susan Gosnell Medical Devices Leave a Comment

2020 is a year etched into the minds of many medical device manufacturers (MDMs). Not only does the United States Food and Drug Administration’s (FDA) UDI compliance date for Class I and non-classified devices fall in that year, it’s also the year the recently approved European medical device regulations (MDR) go into effect. These impending deadlines have MDMs taking a …

Medical Device labeling

A recap of the Medical Device Packaging & Labeling Summit

Susan Gosnell Medical Devices 2 Comments

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?

Susan Gosnell Medical Devices Leave a Comment

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 …

UDI deadline

The Class II UDI deadline is past. Enterprise labeling is the future.

Susan Gosnell Medical Devices Leave a Comment

Last month, the UDI deadline for Class II devices came and went and many medical device manufacturers breathed a collective sigh of relief.  Others are taking advantage of the extension for convenience kits and repackaged single-use devices, or still working to get their labeling and data organized for GUDID submission. Last week, at the Medical Device Labeling Conference in Phoenix, …

UDI compliance date extension

What you need to know about the UDI compliance date extension

Susan Gosnell Medical Devices 2 Comments

On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued an extension letter to device labelers, extending the UDI compliance date to September 24, 2018 for certain Class II devices. The devices impacted by the UDI compliance date extension are classified as: Convenience kits Repackaged single-use devices The letter also clarified that the compliance date for biologic and …

Medical device

European Medical Device Directives – How a small-medium sized medical device company responded to the new regulations

Susan Gosnell Medical Devices Leave a Comment

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 …

Helpful resource in planning for September UDI deadline for Class II device compliance

Susan Gosnell Medical Devices Leave a Comment

Manufacturers of Class II medical devices must comply with the FDA’s Unique Device Identifier (UDI) regulations by September 2016, the latest in a series of deadlines for varying devices. Are you ready? The FDA manages a Global Unique Device Identifier Database (GUDID), to which manufacturers must submit their device details, via one of three accredited agencies. There is a fair …