EU reporting continues to show worrying discrepancies
This article was originally published in Clinica
Executive Summary
The EU still has a long way to go before it can claim that criteria for the reporting of medical device incidents is the same in each of the member states, including those that joined the EU on May 1. A quick glance at the recently updated chart on the website of the European Commission's medical devices unit reveals many gaps and raises questions which could be seen as undermining this most critical element in the medical device regulatory armoury.