by Sam Ireland, on May 5, 2020
The European Parliament has voted to extend the deadline for the implementation of the EU Medical Device Regulations to May 2021, subject to member state approval. As a result, we’re …
Read Storyby Laura Johnson, on November 26, 2019
This article was originally published in MedTech Intelligence. With the next major milestone for EU MDR (Medical Device Regulation) fast approaching, many medical device companies are finding they need to make …
Read Storyby Dalton Litzelman, on October 17, 2019
In the health care sector, medical device labeling is one of the most essential processes in production. Any slight error in your labeling could pose risk towards your patients, and, …
Read Storyby Joe Farrell, on October 1, 2019
What are the regulations around medical device labeling around the world? Medical device labeling is one of the essential processes that goes into producing equipment for the health care sector …
Read Storyby Josh Roffman, on September 18, 2019
UDI rules are expanding to Europe. Is your data storage and access infrastructure ready to comply? This article was originally published in MedTech Intelligence. The 2017 European Union Medical Device …
Read Storyby Sam Ireland, on April 16, 2019
If so, you won't won't want to miss this year’s European UDI Forum, taking place in Brussels, April 24-25. Loftware will be a sponsor at this year's event, which provides an opportunity for leaders from …
Read Storyby Laura Johnson, on July 9, 2018
Medical device labeling requirements around the world are intensifying. As regulations continue to go into effect around the world, compliant and up-to-date medical device labeling has become an essential element …
Read Storyby Craig Hodgson, on May 31, 2018
Heading to GS1 Connect next week in Phoenix? This annual event brings together key influencers and decision makers from Foodservice, Healthcare, Retail Grocery and Apparel to network and participate in …
Read Storyby Craig Hodgson, on May 11, 2018
Labels continue to play a critical role in the safe testing, manufacturing, distribution and use of medical devices worldwide. Not only must they comply with a range of regulatory requirements …
Read Storyby Craig Hodgson, on May 4, 2018
Just as you’ve come to grips with the FDA’s Unique Device Identification (UDI) system, along comes the European Union’s version—and a new set of labeling requirements. The EU’s recently published …
Read Storyby Laura Johnson, on April 20, 2018
Just as medical device companies have achieved a comfort level with their labeling programs to ensure compliance with the FDA's Unique Device Identification (UDI) system, along comes Europe's version of UDI with …
Read Storyby Jay Crowley, on March 29, 2018
On January 12th, FDA published an immediately-in-effect (IIE) guidance document titled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices,” (available here). The guidance states that …
Read Storyby Maureen Perroni, on December 19, 2017
Welcome back to the Loftware blog. We're continuing our dive into the state of enterprise labeling as 2017 ends and 2018 gets underway. Today, we're focusing on medical device labeling and the …
Read Storyby 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 …
Read Storyby Maureen Perroni, on November 20, 2017
Welcome back to the Loftware blog. Today we'll continue discussing the many complex regulations manufacturers must follow when labeling sensitive products for use around the world. Medical devices are one of …
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