Legal Framework: Netherlands
The Netherlands published guidelines for the remanufacturing of single use medical devices in April 2020: >> Staatsblad van het Koninkrijk der Nederlanden.
Legal Framework: Germany
The legal basis for reprocessing under German law (MP Betreiber V) changes on May 26 2021 and will be replaced by medical remanufacturing in accordance with MDR. There are two options: 1) Medical remanufacturing with CE certification Legal basis is Article
Fraunhofer: New Study Shows: Restored Medical Products Can Protect the Climate
Plastics offer very good properties, are often durable materials and are used in all possible areas - from packaging to the construction industry to medicine. If plastic products are circulated for as long as possible, the
Device Med: How Remanufacturing of Medical Devices Helps to Protect the Climate
Plastics have become an indispensable part of our lives. By staying in the cycle for a long time, the products can minimize resource consumption. Many medical devices that have only been approved by the manufacturer for one-time
Rematec: Fraunhofer Research Shows Global Warming Impact Cut in Half by Using Remanufactured as an Alternative to a Newly-Manufactured Catheter
Healthcare as an industry is particularly wasteful and toxic. A study, conducted by Fraunhofer Institute for Environmental, Safety, and Energy Technology UMSICHT, which was published in Sustainability, is the first comprehensive LCA exploring the environmental impact
Fraunhofer Institute Investigates the Restoration of Medical Devices
Many medical devices that have only been approved by the manufacturer for a single use contain plastics, for example electrophysiology catheters (cardiac catheters). A research team from the Fraunhofer Institute for Environmental, Safety and Energy Technology