EU Regulatory Resources
AMDR Response to Swedish MedTech Shadow Report
In December 2020, the Swedish National Board of Health and [...]
AMDR comments to the Slovenian Ministry of Health Proposal
The Association of Medical Device Reprocessors (AMDR) appreciates the opportunity [...]
AMDR Reaction to Swedish Socialstyrelsen Report: Prerequisites for Reprocessing and Reusing Disposable medical Devices in Sweden
The Association of Medical Device Reprocessors (AMDR) applauds the Swedish [...]
AMDR Comments to the European Commission’s Inception Impact Assessment on the Sustainable Products Initiative
The Association of Medical Device Reprocessors (AMDR) appreciates the Commission’s [...]
AMDR Comments to the European Commission’s Inception Impact Assessment on Empowering the Consumer for the Green Transition
The Association of Medical Device Reprocessors (AMDR) appreciates the Commission’s [...]
Commission Implementing Regulation (EU) 2020/1207; Single Use Devices
PDF Version: Commission Implementing Regulation (EU) 2020.1207 COMMISSION IMPLEMENTING [...]
United Nations Development Programme: Sustainable Health Procurement Guidance Note
To have an impact on planetary health requires bold vision, [...]
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 [...]