Reprocessing of Single-use Products – Common Specifications

The implementing regulation (EU) 2020/1207 regarding common specifications for the reprocessing of single-use products was published in the Official Journal of the EU. 
The Medical Device Regulation (MDR) provides for so-called “common specifications” to specify the general safety and performance requirements according to Annex I of the MDR. Certain single-use products are not suitable for reprocessing. The specifications provide guidelines for evaluating the suitability for reprocessing of such single-use products. This includes the analysis of the characteristics in terms of construction, material, properties and planned application.

You continue to describe
– details on commissioning external reprocessors,
– points on premises and equipment,
– the preliminary assessment of the suitability of a single-use product for reprocessing,
– the definition of the reprocessing cycle,
– the maximum number of reprocessing cycles,
– scope and content of the technical documentation,
– process and steps of the reprocessing cycle,
– the QM system and much else
These common specifications came into force in September and will apply from May 26th, 2021

More News & Events