Webinar: 5 Things to Know About Global Med Device Labeling
by Laura Johnson, on November 28, 2017
Just when you thought you had a good grasp—or at least a reasonable understanding—of the FDA’s UDI system and its associated labeling requirements, along comes the EU’s Medical Device Regulations (MDR) as well as other fairly strict, country-specific labeling laws. Are you ready? Can you leverage some of the work you’ve already done with UDI to ensure compliance across your extended supply chain? Will your existing medical device labeling software adapt easily to support a broader scope?
Clearly, if you do business outside the US, you need to be compliant with international regulations.
Published this past May and designed to replace the current Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD), the MDR will require all manufacturers doing business in Europe to re-certify their products, which will also impact what goes on their labels. It’s a complex regulation with several milestone dates over the next few years and companies are advised to plan their transition now to MDR labeling.
Then there’s the UK NHS (National Health Service) initiative that will require GS1 barcodes with associated GTINs to be on all devices that are imported and exported in Great Britain. It’s a very UDI-like regulation, but there are some subtle differences manufacturers will want to understand.
And let’s not forget the stringent requirements coming out of Russia where all medical devices must be registered and certified through Russia’s Federal Service for Control over Healthcare. In addition, all labels and IFUs must be in the local language, among other requirements. Similar stipulations are found in the Eurasian Economic Union (EAEU) med device regulation. What makes compliance with these laws particularly important is the enforcement as customs officials in these countries have been known to seize non-compliant products for extended periods of time.
So, what’s the best approach when dealing with international medical device labelling requirements? A good place to start is to join Loftware and USDM Life Sciences for a special webinar “Global Medical Device Labeling: 5 Things You Need to Know,” taking place next week, Nov. 29 at 10:00 AM ET. We’re pleased to have Jay Crowley, USDM’s Vice President of UDI Services and Solutions, share his expertise and insight to help you better prepare for the road ahead.
Register for the Webinar Today!
Date: Wednesday, November 29, 2017
Time: 10:00 – 11:00 AM EST
Topics planned for the presentation include:
- A quick overview of MDR and EAEU requirements including upcoming deadlines
- Comparison of US and international UDI requirements—and which require special attention
- Implementation challenges and how some companies are overcoming them
- Labeling strategies and technologies to meet and sustain global UDI compliance
Jay is a respected and well-known authority on UDI compliance. Prior to joining USDM Life Sciences, he served as senior advisor for patient safety in the FDA’s Center for Devices and Radiological Health. It was while at the FDA that Jay developed the framework and authored the key requirements for its Unique Device Identification system.
Mark your calendar and register today for what promises to be a timely, informative and highly relevant webinar for anyone involved in the medical device industry. See you then and bring your questions!