The European Union (EU) is concerned about the amount of packaging being delivered with products, including medical devices, into the EU Market, and as a consequence has enacted legislation to control this amount, as well as the recovery and recycling of that packaging.
The Packaging and Packaging Waste Directive (94/62/EC as amended), mandates that producers/importers who place packaged products on the EU market (ie. packaging that protects their products during transportation and handling) must ensure that the amount of packaging is the minimum necessary and does not contain any specified hazardous substances.
The producer/importer has an obligation to report the amount of packaging (by weight and material) placed on the EU market to the relevant national authorities, and be financially responsible for recovering the packaging.
Our Environmental Systems Specialist can help you:
  • Identify relevant packaging types

  • Collect the necessary data for national authorities

  • Review device packaging to ensure it meets the appropriate criteria

  • Identify relevant packaging standards

  • Develop standard operating procedures for packaging review and data collection

Contact us for more information on how GEMARMED can help you meet the EU legal requirements for packaging, or to talk with our Environmental Systems Specialist.