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 these technical comments, we would also like to suggest that the opening Article 1 (‘Subject Matter’) should contain a clear statement that the reprocessing activities referred to in Article 17(2) of the Medical Devices Regulation 745/2017 (“the MDR”) are outside the scope of this Commission Implementing Regulation.
Article 1 of the draft Commission Implementing Regulation already states that the purpose is (only) to lay down rules for the application of MDR Article 17(3) and not 17(2). Nevertheless, when we consulted our members, it was not clearly evident to all companies' staff that this Commission Implementing Regulation applies only to reprocessing of single-use devices conducted by health institutions for their own in-house re-use, i.e., without further market circulation within the Union.
Finally, while MedTech Europe is pleased to see progress on this important MDR Implementing Act, we regret that stakeholders were consulted on such a complex topic during the Summer vacation. We would be grateful if the Commission could ensure that future stakeholder consultations of this nature are better timed. Thank you.
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