The FDA does not intend to enforce the GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices, regardless of whether they are consumer health products, before December 8, 2022.
“The MedAccred Labeling, Printing and UDI Task Group’s role is to provide medical device companies with structure and requirements to assist in identifying and implementing industry best practices for global market compliance.”
New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.
2022 is now upon us, hopefully marking the end of a very disruptive couple of years. Global challenges, from supply chain shortages to remote services, have driven digital innovation and change in the way we work across all sectors. The medical device industry is no different and going forward, having learned from the experiences of 2021.
Clinical Trials Labeling and Regulated Content Management Added to Cloud-Based Platform
Due to rapidly evolving regulatory landscape and manufacturing demands, label requirements and the information they contain are constantly changing. Here’s how medtech organizations can manage the process.
Automation handling with integrated controls can assist with laser marking for all shapes, sizes and materials used in the manufacture of medical devices. This approach can offer flexibility, along with the ultimate precision necessary, to support the UDI system, which provides a clear framework that defines the form in which information should be encoded on the device in accordance with its classification.
With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements.
Anyone can read the regulation. The challenge is in how to apply it to your company’s structure and product line.
Labeling is as critical as quality for medical device products. If a manufacturer can’t shift labeling to meet production in an agile manner, their products may not reach their destination.