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Achieving the CE mark: getting it right first time.

Manufacturers are often unable to place the CE mark on all their medical devices immediately following an audit by a Notified Body because of deficiencies in documentation or procedures. In this article, the author uses the audit experience of a Notified Body to highlight some of the common problem areas. Manufacturers will be able to use this information as a checklist for their own system and significantly reduce the chance of delays in their CE-marking schedule.