Underperformance of EU medtech industry overseers pinpointed in joint assessment initiative
This article was originally published in SRA
Several EU regulatory authorities responsible for the designation of medical device notified bodies changed their processes following a two-year voluntary initiative that identified problems – dubbed "opportunities for improvement" in a European Commission report– in the way they work1. Among other things, the initiative highlighted shortcomings related to the planning, scope and depth of surveillance assessments undertaken by NB designation authorities during this period.
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