Reprocessing of Medical Devices: What the MDR Stipulates
While Article 17 of the MDR provides unified, detailed European requirements for reprocessing single-use devices—replacing previous national regulations— EU-wide harmonization is not fully achieved. Each member state decides whether reprocessing is permitted at the national level through an opt-in/opt-out procedure and notifies the European Commission of their decision. Under EU law, two pathways for reprocessing are recognized: CE reprocessing and CS reprocessing.
Conformité Européenne – CE Reprocessing
CE reprocessing is governed by Article 17(2) of the MDR, which designates any entity reprocessing a single-use device for further use in the EU as its manufacturer. Therefore, reprocessors must fulfill all obligations of a manufacturer, including those for traceability and product liability.
In practice, Vanguard acquires used devices such as ultrasound scissors and electrophysiology catheters from hospitals, reprocesses them, and subsequently markets them as a medical device manufacturer. Clinics can purchase and use these products with confidence in their safety and functionality.
Common Specifications – CS Reprocessing
Articles 17(3) to 17(5) of the MDR allow single-use device reprocessing under national law without requiring full compliance with manufacturer obligations, provided the devices meet Common Specifications (CS) outlined in Commission Implementing Regulation (EU) 2020/1207. For external reprocessors, this means products must be returned specifically to the healthcare facility from which they were collected, maintaining a closed-loop system where healthcare facilities retain ownership of the devices.
However, a limitation exists: due to previous regulatory requirements, no certification body is currently available to certify CS reprocessing. Since the MDR’s implementation, only CE reprocessing of single-use devices has been legally permitted in Germany. CS reprocessing is allowed in Lower Saxony and Saxony-Anhalt through regulatory allowances. Since no EU-wide certification body for CS reprocessing exists, Vanguard and other companies offering CS reprocessing operate under these conditions with oversight from the relevant regional authorities.
CE vs CS in Practice: Different Certifications, Same Process
Though Vanguard’s reprocessed products receive different certifications and adhere to varying regulatory requirements, they all undergo the same rigorous reprocessing steps—including disassembly, disinfection, reassembly, sterilization, and testing. Consequently, products from both reprocessing models offer safety, functionality, and quality equivalent to new OEM products.
Established Practice: Hundreds of Thousands of Safely Reprocessed Devices
With over 25 years of experience, Vanguard AG has made reprocessing a core component of its business. Since 2011, we have offered both CS and CE reprocessing, establishing ourselves as a medical device manufacturer for our distributed products. Over the years, hundreds of thousands of devices have been processed in our facilities without posing any safety risk to patients. Our data and extensive experience speak for themselves.
