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eMDR Rule Could Hurt Device Companies
A proposed rule requiring device manufacturers to submit all medical device reports (MDRs) electronically could hurt both multinational and small companies,
industry says.
As a company with a 100 percent paper-based regulatory system, Grove Medical says switching to electronic reporting — a process that could cost it thousands of dollars — would be a significant burden. The company reports fewer than five MDRs a year, it says in comments to the proposed rule.
Larger device companies like Covidien say switching to an eMDR system one year after a rule is finalized could be impossible.
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