Trusted Information Resource
A particular company supplies a respiratory medical device (Class IIa). The primary Standard indicates that an integral connecting part should conform to the requirements of a secondary Standard. However, the company in question indicates; clearly in its IFU, that this connecting part does not meet the test requirements of this secondary Standard. As the overall device is CE marked is this illegal, as it does not conform fully to the Standard? If nothing else you would expect the company’s NB to raise this as a non-conformity. Thoughts?