Health institutions reprocessing single-use medical devices
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A health institution reprocessing single-use devices will have to comply with Article 17 of the MDR. The Regulation adds strict conditions for reprocessing of single-use medical devices, and places full product liability on the reprocessor. In addition, reprocessing may only take place when authorised under national law and in accordance with the provisions of the MDR. Some EU countries may have stricter provisions, or even ban reprocessing.
The reprocessor must assume all responsibilities of the original manufacturer who will no longer be mentioned on the label (but will continue to appear on the Instructions for Use).
Key Resources
- Transition Timelines from the Directives to the Regulations - Medical Devices and in vitro Diagnostic Medical Devices
- Сроки перехода от директив к Регламенту о медицинских изделиях и Регламенту о медицинских изделиях для диагностики in vitro
- الجداول الزمنیة للمرحلة الانتقالیة من التوجیھات إلى اللوائح الأجھزة الطبیة والأجھزة الطبیة التشخیصیة في المختبر
- 指令から規制への移行スケジュール 医療機器および体外診断用医療機器
- CAMD Transition Sub Group FAQ – MDR Transitional provisions
Legfrissebb dokumentumok
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A közzététel időpontja23 Március 2021A dokumentum az alábbi rovatban jelent meg: Medical Devices - Sector, Medical Devices - Topics of Interest
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A közzététel időpontja08 Március 2021A dokumentum az alábbi rovatban jelent meg: Medical Devices - Topics of Interest
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A közzététel időpontja18 Január 2021A dokumentum az alábbi rovatban jelent meg: Medical Devices - Sector, Medical Devices - New regulations, Medical Devices - Topics of Interest
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