Common specifications for reprocessing of single-use devices published

The MDR (Regulation (EU) 2017/745) allows reprocessing of single-use devices only where it is permitted by national law. In fact, when reprocessed and used within a health institution, the MDR allows Member States not to apply all the rules relating to manufacturers’ obligations laid down in that Regulation (Article 17(3)). However, one of the conditions for such reprocessing is that it is performed in accordance with common specifications (‘CS’).

The recently issued Regulation (EU) 2020/1207 lays down rules governing both the above and cases where single-use devices that are reprocessed by an external reprocessor.


The following are its key points:

  • Actors concerned:
(1) ‘reprocessor’ means the health institution and the external reprocessor reprocessing single-use devices;


(2) ‘external reprocessor’ means the entity reprocessing single-use devices at the request of a health institution.


  • If reprocessing is carried out by an external reprocessor a written contract with the health institution shall be in place (Article 3)


  • The personnel involved in reprocessing is to be sufficient, and sufficiently qualified (Article 4)


  • A preliminary assessment of the suitability of a single-use device is required (Article 5)


  • The original intended purpose of the single-use device shall not be changed by reprocessors (Article 6)


  • The reprocessor shall establish a monitoring process to verify, for instance, that the single-use device is not withdrawn from the market, the certificate of conformity is not suspended, and the device has not been subject to restrictions for safety reasons (Article 6)


  • Reprocessors shall draft the technical documentation on its activities


  • QMS (Quality Management System), annual audits and the reporting of incidents are mandatory for the reprocessor


This Regulation enters into force on the twentieth day following that of its publication in the Official Journal of the European Union and shall apply from 26 May 2021.

Read the whole implementing decision on this link at

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