EU Regulatory Resources
AMDR filed comments to the European Commission’s Inception Impact Assessment on Waste Shipment Regulations
AMDR appreciates the Commission’s communication on a European Green Deal [...]
Compliance Navigator BSI: Reuse of single-use medical devices in the European Union
Article 17 of the European Medical Devices Regulation 2017/745 (MDR) covers [...]
European Commission, Implementing Regulation, Single-Use Medical Devices – Safety and Performance Requirements for Reprocessing (2019)
“…Regulation (EU) 2017/745 allows reprocessing of single-use devices only where [...]
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European Union, Medical Device Regulation of 2017, Regulation (EU) 2017/745 of the Euroepan Parliament and of the Council 5 April 2017, Article 17: GalleryEuropean Union, Medical Device Regulation of 2017, Regulation (EU) 2017/745 of the Euroepan Parliament and of the Council 5 April 2017, Article 17:
European Union, Medical Device Regulation of 2017, Regulation (EU) 2017/745 of the Euroepan Parliament and of the Council 5 April 2017, Article 17:
Single-Use Devices and their Reprocessing “…The reprocessing and further use [...]
United Kingdom, Medicines & Healthcare Products Regulatory Agency:
Single-Use Medical Devices: UK Guidance on Re-Manufacturing (2016) “…Single-use devices [...]
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Germany, Commission on Hospital Hygiene and Infection Prevention at the Robert Koch Institute and the Federal Institute for Drugs and Medical Devices (BfArM), Hygiene Requirements for the Reprocessing of Medical Devices (2012) GalleryGermany, Commission on Hospital Hygiene and Infection Prevention at the Robert Koch Institute and the Federal Institute for Drugs and Medical Devices (BfArM), Hygiene Requirements for the Reprocessing of Medical Devices (2012)