Manufacturers Uncertain Due To GS1 Compliance Regulations

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Manufacturers Uncertain Due To GS1 Compliance Regulations

While most medical device manufacturers in Europe currently meet GS1 standards according to Packaging World, many are uncertain about launching new products after questions were raised regarding new regulations in the injectable and medical device sectors at Pharmapack Europe. Essentially, manufacturers want to avoid having to make changes to packaging and labeling mid-launch, which has raised many concerns. According to Joel Guillou, Consultant Regulatory Affairs and Market Access and Director at International Society for Pharmaceutical Engineering, France, "The revision of medical device directives is going to create periods of upheaval and new constraints, but it can also bring real opportunities to companies." Some news resources claim the upcoming changes for complying with GS1 standards may include unique device identification, new rules regarding clinical evidence, and unannounced audits. Why the push for new standards for GS1 compliance? According to some, the primary driver of this push is the expanding counterfeit black market, a huge issue in the pharmaceutical industry. Around the world, counterfeit pharmaceuticals is a multi-million dollar market that not only damages manufacturers' brands, but creates economic risks and serious or even life-threatening health issues. Ultimately, improved regulations will benefit all involved. As providers of industrial traceability solutions for many industries including pharmaceutical, electrical equipment, foods, beverages, dairy, tubes, cosmetics, and more, we realize that counterfeiting is a burgeoning problem for pharmaceutical manufacturers around the world. Markem-Imaje invites you to learn more about our CoLOS Traceability software, and our industrial coding and marking systems, trusted by manufacturers around the globe.

January 10, 2014
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