FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Devicemakers Push Bask Against EU Plan for Reprocessing Single-Use Devices

Sept. 3, 2019

The European Commission’s specifications for reprocessing single-use devices have raised concerns among devicemakers who want the commission to  revise or delete some of the specifications.

Commenters were particularly vocal about the requirement to list technical information about their devices on their websites. MedTech Europe argued that a manufacturer’s technical documentation is proprietary information, so the manufacturer is under no obligation to list such information.

The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) noted that there is no legal obligation for a manufacturer to provide access to technical documentation and said the regulator’s expectations should be revised or the provision should be deleted.

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