medical device and labeling and compliance

Addressing Medical Device Labeling & Compliance Challenges

Susan Gosnell Life sciences, Medical Devices Leave a Comment

The medical device industry is poised for growth in the coming years. This presents opportunities for many, but also immense challenges and greater strain on the supply chain. And considering that the medical device industry is highly regulated, these companies also have to pay special attention to varying requirements across borders, lengthy approval processes and non-compliance penalties – all of …

EU MDR

Five steps to EU MDR-compliant labeling

Susan Gosnell Life sciences, Medical Devices Leave a Comment

The EU MDR one-year delay gives you the opportunity to take a more measured, strategic approach to compliance. However, it’s important to use the time wisely. In this blog, we highlight five steps that will help you on the road to UDI compliance. We’ll also talk about how to review your existing labeling processes and ensure you’re using the best …

EU MDR

As the EU MDR deadline approaches, seize the opportunity to digitize quality assurance

Susan Gosnell Cloud computing, Life sciences, Medical Devices Leave a Comment

The postponement of the EU MDR deadlines has given medical device manufacturers a unique opportunity to digitize quality assurance as they take steps to comply with MDR requirements. By seizing this opportunity, MDMs can simplify the compliance process, ensure greater label accuracy and, ultimately, get their products to market faster. If you’re facing the EU MDR deadline, the last thing …

medical device webinar

Webinar recap: How to comply with medical device UDI requirements

Susan Gosnell Life sciences, Medical Devices Leave a Comment

FDA Class I just the beginning  There is a wave of regulations hitting medical device manufacturers (MDMs) with international operations. In addition to the upcoming deadlines for US FDA Class I and the EU MDR date of application, the in vitro diagnostic regulation (IVDR) date of application goes into effect in May 2022. After that, there are a number of other application …

Medical Device Labeling

Managing regulatory labeling challenges in the medical device sector

Ken Moir Medical Devices 1 Comment

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 labeling

Medical device community shares insight on label management tools

Susan Gosnell Medical Devices 1 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 …

Medical Device labeling

A recap of the Medical Device Packaging & Labeling Summit

Susan Gosnell Medical Devices 6 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 …

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 …

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

UDI labeling: common mistakes and best practices

Marko Vrbnjak Medical Devices 1 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 …