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Regulatory Focus™ > News Articles > 2019 > 8 > US Group Further Rebuffs EC’s Specifications for Reprocessing Single-use Devices

US Group Further Rebuffs EC’s Specifications for Reprocessing Single-use Devices

Posted 30 August 2019 | By Ana Mulero 

US Group Further Rebuffs EC’s Specifications for Reprocessing Single-use Devices

Following the closing of the comment period on the reprocessing of single-use medical devices under the EU’s medical device regulation (MDR), the US-based Association of Medical Device Reprocessors (AMDR) reacted to the issues and concerns other industry stakeholders raised.
“AMDR compiled a larger response and reaction to the various other comments submitted” to the European Commission’s (EC) draft implementing act for common specifications (CS) on single-use devices,” AMDR President Daniel J. Vukelich told Focus. The draft implementing act was met with strong criticism as all but eight Articles are of issue and clear pushback against Article 5 across most commenters. It is only the second implementing act to be issued for MDR.
AMDR is among those calling on the EC to delete provisions of Article 5 due to a lack of a legal basis for obligations on manufacturers, though it requests various other revisions as well. In reviewing others’ comments, the group echoes many of the issues raised by the German Hospital Federation throughout the response shared with Focus via email. But AMDR’s reaction to MedTech Europe’s (MTE) comment adds to the pile of criticism on the draft implementing act.
On MTE’s suggestion to inform of corrective and preventive measures, AMDR “respectfully disagrees” because “altering the circumstances for which informed consent is required could have broad implications for the larger device industry.” AMDR also disagrees with MTE’s suggestion to remove original equipment manufacturers’ names/markings from the devices.
Regulatory agencies would no doubt want to know everyone that has had a hand in the life cycle of a product and the proposed CS already requires reprocessors to trace all devices,” AMDR says. “If the MDR intended to have reprocessors remove” original equipment manufacturer labels from the devices, “it would have said so, as it does with regard to labels.”


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