The European Commission (EC) has outlined the common specifications for the reprocessing of single-use medical devices under the European Union’s (EU’s) medical device regulation (MDR). The common specifications have been issued via a draft implementing regulation in alignment with criteria in Article 17(3) of the MDR.
Provided that the safety and performance profile of the reprocessed device is equivalent to that of the original device and that the reprocessing is performed in accordance with the common specifications, EU member states may decide not to apply rules relevant to manufacturers’ obligations for single-use devices reprocessed and reused within health institutions.
In the implementing regulation, the EC discusses devices incorporating medicinal substances and implantable devices and notes that not all single-use devices are suitable for reprocessing.
The implementing regulation is split into six different chapters. The first chapter outlines and distinguishes the term “reprocessor” from the term “external reprocessor”, whilst the second chapter discusses risk management. Chapters III, IV and V address reprocessing procedures, quality management systems and traceability. Chapter VI states that the regulation shall apply from 26th May 2020.
In June 2019, the EC initiated the process for harmonisation of standards under the MDR and the in vitro diagnostic regulation (IVDR). The implementing regulation has been released ahead of the target in the MDR/IVDR rolling plan of essential implementing acts and actions, however the draft standardisation request has been subjected to criticism.
To read the implementing regulation on single-use medical devices – safety and performance requirements for reprocessing, please click here.