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Common Specifications for the reprocessing of single-use medical devices

Single market

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Public consultation

ID: 11888

Lobbying Activity

4 responses

Consultation response

MedTech Europe, 20 Aug 2019

MedTech Europe - the European trade association representing the medical technology industries, from diagnosis to cure - is pleased to submit input to this consultation. For ease of viewing, the consolidated technical comments received from our members are enclosed as single document. Beyond…

Consultation response

European Coordination Committee of the Radiological, Electromedical and healthcare IT Industry, 20 Aug 2019

COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries. We appreciate this opportunity to provide feedback to the draft Implementing Regulation for Single-use medical devices - safety and performance requirements for…

Consultation response

Technische Universitaet Berlin, 15 Aug 2019

My comments to the Common specifications for the reprocessing of single-use medical devices (as Chair of Medical Technology at the Technical University Berlin) are in the attachment.

Consultation response

, 14 Aug 2019

Recitals 1-8: Per MDR Article 17(5), the CS 'shall address the application of the general requirements on safety and performance..."; recitals 2, 3, 4 and 7 do not do this but rather provide additional requirements beyond the pervue of the CS. Additionally, MDR Article 17(2) deems reprocessors to…