Hello, we market a legacy device class I under the directive and will become class IIA under regulation 2017/745, my question is in relation to the QMS update, is it going to concern only post-marketing surveillance (procedure, plan and PMS report)? And for clinical evaluation, we have a report that was written under the directive, do we need to create a clinical evaluation procedure and update the CER report, however no changes have been made for our medical device software.
thank you again
thank you again