Regulatory Articles

41. EU Medical Device Regulation (MDR): The Useful Guide To Labeling Compliance 4/24/2019

    Compared to the previous European Regulation MDD, the new EU MDR/EU IVDR offer a change from the pre-approval stage to a life-cycle approach. One of the new aspects of the legislation is the introduction of Unique Device Identifiers (UDI) to products, allowing the ability to trace a device from its manufacturer through the supply chain to the final end user. Whether producing medical devices within Europe or supplying to Europe from the rest of the world, as a manufacturer or supplier, you will need to adhere to the new EU MDR/EU IVDR. This article offers useful guidelines for adhering to the new EU MDR/EU IVDR.

42. OriGen Biomedical Implements PRISYM ID'S Cloud Based Labeling Solution To Automate Processes And Achieve Regulatory Compliance 4/24/2019

    OriGen Biomedical is a leading producer of cryopreservation, cell culture, and ECMO respiratory products. Their focus is to produce a range of products to support the treatment of respiratory distress, cancer, genetic conditions, and other life-threatening diseases. OriGen Biomedical depended on a manual solution for managing labeling for their products, but it was vital for a new solution to be easy to implement, comprehend, and use and to enable rapid deployment to market for new products. The PRISYM SaaS was selected due to its compliance-first approach and it being hosted within a cloud environment exclusive to life sciences organizations, facilitating speedy implementation.

43. The Useful Guide To Unique Device Identification 4/24/2019

    For the sake of patient safety, the ability to track and trace medical devices at a global level is paramount. However, there are some key considerations to be aware of when implementing Unique Device Identification (UDI). This article offers guidance on the use of UDI and what its benefits are.

44. Medical Device Label: Before And After EU MDR/IVDR 4/24/2019

    EU MDR introduces additional information that needs to be included on labels, forcing organizations to design new label templates that make room for data not previously part of the labeling system. It’s both a design and a data challenge, and they must quickly be addressed to avoid a sticky situation. 

45. PRISYM SaaS: A Compliance Ready Solution For Small To Medium Medical Device Organizations 4/24/2019

    The burden of meeting FDA requirements is often most acutely felt in small to medium-sized organizations that do not have the resources to implement the type of enterprise label lifecycle management solution that can automate much of the compliance process and reduce the load. 

46. Barcode Considerations For Medical Device Labeling 4/24/2019

    Barcodes labeling and packing are a critical part of the life sciences and medical devices products. But how do you know that your barcode and packaging design surrounding it meets what is required? This article presents a number of considerations for the use of barcodes in medical device labeling.

47. Will Your Labeling Strategy Assure Compliance With EU MDR? 4/22/2019

    The new regulation, which entered into force in May 2017, imposes major new rules on companies involved in the design, manufacture, approval and commercialization of devices that are sold in the EU. Will your labeling strategy assure compliance With EU MDR?

48. The Recurring Insanity Of Med Device Labeling Recalls 4/22/2019

    Companies’ continued reliance on manual processes and disparate labeling systems often culminates in pricey product recalls. In 2018, nine percent of all medical device recall events – and the return of over a million units – were due to labeling issues. 

49. Providing A Labeling Backbone For Medical Device Manufacturer: Boston Scientific 4/22/2019

    Boston Scientific, one of the world’s largest medical device manufacturers, was looking to standardize on a single labeling system. The project initially arose when a worldwide branding exercise highlighted the huge variances in label formats and styles on secondary packaging; standardizing on a single labeling system would offer consistency, increase efficiency and compliance.

50. EU MDR Labeling Compliance: Learning The Lessons From UDI 4/22/2019

    As organizations struggle to meet the challenges of EU MDR, there are many lessons to be learned from the UDI experience. This paper presents those learnings, primarily through the lens of the labeling function, but with an appreciation of the wider context of the full regulations.