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 [...]
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 [...]