New requirements placed on European notified bodies aim to raise standards
This article was originally published in Clinica
Executive Summary
Notified bodies in the European Union will face extensive new documentation requirements if they are to ward off their critics who argue that standards are lax and uneven. Recommendations in a new working document from the European Commission for the designation and monitoring of the third-party certification bodies, which assess products for their compliance with the EU medical device directives, are far more comprehensive than the requirements laid out in the directives themselves.
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