What does it mean in practice?
Unlike CE reprocessing, CS reprocessing is carried out without the full obligations of the original manufacturer, as regulated by the respective national legislation. The healthcare facility retains ownership of its devices, which means that in the case of external reprocessing, the product must be returned to the same healthcare facility from which it originated.
Find more details in the original article at Green Deal Duurzame Zorg.
CE vs. CS remanufacturing at a glance:
Medical Remanufacturing with CE (MDR Article 17, Paragraph 2)
- Business Model: Product Sale
- Ownership transferred to Vanguard AG
- Product is CE certified
- Quality Management certification required
- The Medical Remanufacturer assumes all MDR manufacturer responsibilities, including product liability
- Contract required
Medical Remanufacturing with CS (MDR Article 17, Paragraphs 3 and 4)
- Business Model: Service
- Product remains in the possession of the clinic
- Product is CS certified
- Quality Management certification required
- Vanguard AG assumes core manufacturer responsibilities after restoration, including product liability
- Contract required
If you are interested in the detailed legal situation, you can find all the information here.
Have more questions? Please contact our customer service.
