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 are reprocessed by an external reprocessor.
The following are its key points:
- Actors concerned:
- ‘reprocessor’ means the health institution and the external reprocessor reprocessing single-use devices;
- ‘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- The reprocessor shall establish a monitoring process to verify, for instance, that the single-use device is not withdrawn from the market, the certificate of conformity is not suspended, and the device has not been subject to restrictions for safety reasons (Article 6);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 shall apply from 26 May 2021.
Carlos Francisco Marín Barrios
Regulatory Affairs Department
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Reference: 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 (Text with EEA relevance): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32020R1207