W
welshery
Dear All
I have been asked to establish the requirements for CE marking a Class I medical device. Am I right in thinking that I only need to follow Annex VII of the medical devices directive or do I also have to answer all the statements in the essential requirements section too?
Many thanks in advance of your help.
I have been asked to establish the requirements for CE marking a Class I medical device. Am I right in thinking that I only need to follow Annex VII of the medical devices directive or do I also have to answer all the statements in the essential requirements section too?
Many thanks in advance of your help.