A mid-pilot program update from the Medical Device Single Audit Program shows the number of interested manufacturers spiked sharply in July, but is still a far cry from the end-of-2016 target of 330 participating companies. However, the pilot is meeting auditor recruitment and training goals.
Although international regulators are seeking 330 manufacturers to participate in the three-year Medical Device Single Audit Program pilot, they have recruited only 45 as of the 18-month midway point, according to an MDSAP Mid-Pilot Status Report
released Sept. 10 by FDA.
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In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.
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The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.
