Reprocessing of medical devices
‘Reprocessing’ refers to a process carried out on a used device in order to allow its safe reuse. It includes its cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device.
According to the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices, reprocessing and further use of single-use devices may only take place where permitted by national law.
Both official texts describe the new responsibilities of the natural or legal persons who reprocesses a single-use device to make it suitable for further use: they shall assume the obligations incumbent on manufacturers, especially relating to traceability.
More on reprocessing of medical devices
- Outcome of the first public consultation on the reprocessing of medical devices
- Workshop on reprocessing of medical devices, December 2008
- Report on reprocessing medical devices in the EU in accordance with Article 12a of Directive 93/42/EEC
- Health institutions reprocessing single use medical devices