EU: Common specifications for reprocessing single-use devices set by the European Commission
On August 19th, 2020 the European Commission implemented regulation as regard common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR).
Under the MDR, single-use devices may be reprocessed where permitted by national law.
Reach out to Meditrial to know where in the EU you can reprocess your device and how to get your documentation ready for it.
The regulation contains some changes from the draft version released for comment in July 2019 but most of the chapters remained unchanged. Article 5 has been updated to reflect the delayed launch of Eudamed. This article sets the requirement for healthcare facilities to review manufacturers’ technical documentation as part of their assessment of whether a single-use device can be reprocessed.
Reprocessors are obliged to establish a monitoring process to verify “that the single-use device is not withdrawn from the market; the certificate of conformity of the single-use device has not been suspended, withdrawn or is not subject to restrictions; the use of the single-use device is not subject to restrictions for safety reasons.”
The Regulation provides a requirement for health authorities to send copies of serious incident reports to the original manufacturer and, where applicable, to an external reprocessor. Moreover, the regulation no longer demands that the traceability system records on which patients reprocessed single-use devices have been used.
For more details please see the Commission Implementing Regulation.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
