EU MDR requires significant reforms to the device labeling process. Manufacturers must ensure that identifiers are correctly applied to products, and that key data elements and formats are accurate. In addition, manufacturers need to have access to centralized data, audit tracking, robust security controls, eSignature capabilities and strong workflow management to ensure compliance.
New directives and guidance aim to connect patients, physicians and other stakeholders across the healthcare ecosystem with a consistently up-to-date information source for product and safety information that isn’t dependent on paper. Schlafender Hase’s Peter Muller explores the promise of e-labeling and practical next steps required to deliver on these directives.
More and more, the quality of real-world evidence (RWE)—gathered from remote patient monitoring data, product and disease registry data, and patient feedback—determines whether a medical device is approved and, in some instances, for how long. Yet some medical device manufacturers are missing an important opportunity to collaborate with clinical registries in capturing this data and driving value.
By applying HFE principles early on, packaging design can evolve beyond usability evaluations in product development cycles to ultimately ensure a better user experience and safe execution.
Life sciences companies have a lot of factors to consider when it comes to labeling. Understanding the global labeling regulations for patient safety and how enterprise labeling solutions can help companies achieve compliance while assuring speed to market, and labeling system validation and auditability, can save resources and reduce costly errors.
Steps to ensure your medical device labels are in compliance with global regulations and have the longevity to withstand your device’s intended use.
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 annual SupplyTech Breakthrough Awards program honors excellence within the supply chain and logistics sectors.
“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.”
Following Karl Storz’s recall of urological endoscopes, the agency wants to make sure that healthcare providers have seen the company’s urgent labeling update involving sterilization methods.