EU countries may decide not to apply all the manufacturers obligations laid down in the MDR to single-use devices that are reprocessed and used within a health institution. If that is the case, a health institution reprocessing and reusing single-use devices should ensure that
- safety and performance of the reprocessed device is equivalent to that of the original device
- reprocessing is performed in accordance with common specifications (Commission Implementing Regulation (EU) 2020/1207) detailing requirements concerning risk management, validation of procedures for the entire process, product release and performance testing, quality management system, reporting of incidents and traceability
EU countries may decide to apply same rules applicable to health institutions to single-use devices reprocessed by an external reprocessor, if the reprocessing is performed at the request of a health institution and the reprocessed device is returned to that health institution.
EU countries may also maintain or introduce national procedures that are stricter than those laid down in the MDR.
Detailed information on national rules are available on the page National rules on reprocessing of single-use devices.
- Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices
- National rules on reprocessing of single-use devices