41E
In forceWhat this Part is about
Volume 2s 41B-Endnotes
Chapter 4Medical devices
Part 4-4Conformity assessment certificates
41E What this Part is about
The Secretary can issue a conformity assessment certificate (which may be limited to some medical devices) in respect of a manufacturer of medical devices, signifying one or more of these:
(a)
that relevant quality management systems have been applied to the device;
(b)
the essential principles for the device have been complied with;
(c)
other certification requirements of the conformity assessment procedures have been met.
Note:
A conformity assessment certificate may be required for an application to include a kind of medical device in the Register to pass preliminary assessment: see paragraph 41FDB(2)(e).
Research tools for this sectionSubscription
The statute text is free to read above. View subscription options to unlock the case-law research tools for each provision.