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Device Reprocessing Under New EU Regulations Puts Burden On Commission

This article was originally published in SRA

Executive Summary

Reprocessing and further use of single-use medical devices in the EU will only be able to take place when permitted by national law, according to the texts of the new EU regulations for devices and IVDs, which were agreed by the Council of the European Union and the European Parliament on May 25, and made publicly available this week1. In addition, if the national law allows it, then those who reprocess must meet the requirements laid down in the Medical Device Regulation, once the legislation is adopted.

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