"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.
When establishing the requirements for the reprocessing and further reuse of single-use devices, Regulation (EU) 2017/745 (MDR) on medical devices uses explicitly the term reprocessing.
When establishing requirements for reusable devices, the Regulation does not explicitly use the term reprocessing and refers to ‘the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation appropriate to the Member State or Member States in which the device has been placed on the market’.
While single-use devices are intended by the manufacturer to be used only one time, reusable devices are intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out. Therefore, MDR establishes different responsibilities and requirements for reprocessing of single-use devices and reusable devices.
Reprocessing of single-use devices
According to Article 17 of MDR, reprocessing of single-use devices is possible only if permitted by national law.
If reprocessing of single-use devices is permitted, any natural or legal person who reprocesses these devices to make them suitable for further use within the Union (the reprocessor) will assume the obligations laid down in MDR that are required to manufacturers.
By way of derogation, EU countries may decide not to apply all the rules relating to manufacturers obligations laid down in the MDR to single-use devices that are reprocessed and used within a health institution (detailed information are available on the page Health institutions reprocessing single-use devices).
The reprocessor must assume all responsibilities of the original manufacturer, which will no longer be mentioned on the label (but will continue to appear on the Instructions for Use).
EU countries have the obligation to notify the European Commission of the national laws on reprocessing of single-use devices introduced by Article 17(3) of MDR. EU countries that permit the reprocessing of single-use devices may maintain or introduce national rules under Article 17(9) of MDR that are stricter than those laid down in the MDR. These national rules have to be notified to the Commission (detailed information are available on the page National rules on reprocessing of single-use devices).
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
- National rules on reprocessing of single-use devices