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.
The GMP Letter