Obtaining CE mark - timelines" ... Given the straightforward classification process and the focus on safety and performance, a CE mark can be usually obtained in a relatively short time. If the company has a quality system in place in line with ISO 13485 and the Technical File is complete, the timeline can range from two to three - four months after quality audit and file submission. ... "
[url=https://]https://www.medical-risk.com/project-management/ce-marking[/url]
EOM.