Medical Device labeling

A recap of the Medical Device Packaging & Labeling Summit

Susan Gosnell Medical Devices Leave a Comment

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 …

Common UDI label mistake: The barcode prints over the edge of the label

UDI labeling: common mistakes and best practices

Marko Vrbnjak Medical Devices Leave a Comment

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 …

Who bears responsibility for submitting UDI data to the GUDID

Who bears responsibility for submitting UDI data to the GUDID?

Reed Tech Medical Devices Leave a Comment

The FDA has specified in its Final Rule on Unique Device Identification (UDI) that medical device labelers marketing their products in the United States are required to submit data records to its Global Unique Device Identifier Database (GUDID, pronounced “Good-ID”). Which company qualifies as the device labeler? The next question to ask is which company (or companies) involved in bringing …

Speach at UDI compliance conference

Europe is closely watching UDI

Marko Vrbnjak Medical Devices Leave a Comment

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 …

UDI issuing agencies

How to Choose a UDI Issuing Agency

Marko Vrbnjak Medical Devices Leave a Comment

With the advent of compulsory Unique Device Identification (UDI) for medical device labels, companies in the sector must select a device identifier issuing agency. The device identifier itself – a numeric or alphanumeric code – must include a device component identifying the labeler and the particular version of the device, as well as a production component, which identifies the individual …