The Commission of the European Union (EU) has issued common specifications for the reprocessing of single-use medical devices.
Published in mid-August in the Official Journal of the European Union, Commission Implementing Regulation (EU) 2020/1207 provides further clarification on the EU’s Medical Device Regulation (EU) 2017/745 requirements regarding the reprocessing of single-use medical devices.
Under 2017/745, manufacturers of single-use devices may be exempt in some EU Member States from certain obligations for reprocessing, provided that the reprocessing protocol “is performed in accordance with common specifications (‘CS’).” Published in mid-August in the Official Journal of the European Union, Commission Implementing Regulation (EU) 2020/2017 details those common specifications for single-use medical devices that are reprocessed by an external reprocessor.
The common specifications in the Regulation include procedures and steps of the reprocessing cycle, and requirements for the implementation and maintenance of a quality management system for reprocessing activity. It also addresses issues related to the traceability of single-use devices.
The requirements of the Regulation apply from May 26, 2021.