H
Hrobot
Hi,
I have moved on from a medical device environment to a autoinjector drug device environment which relates to drug submission rather than 510(k). This device falls under the medicinal drug directive.
My question is regarding
-if hazard analysis (identify hazard, clasification, risk control measures) is required at all,
- declaration of conformity is needed for EU,
- a separate technical file is needed for EU. (Conformance to Essential requriements is needed but does this have to sit in a technical file or can it sit in the submission document.
Thanks in advance for your input.
hrobot
I have moved on from a medical device environment to a autoinjector drug device environment which relates to drug submission rather than 510(k). This device falls under the medicinal drug directive.
My question is regarding
-if hazard analysis (identify hazard, clasification, risk control measures) is required at all,
- declaration of conformity is needed for EU,
- a separate technical file is needed for EU. (Conformance to Essential requriements is needed but does this have to sit in a technical file or can it sit in the submission document.
Thanks in advance for your input.
hrobot