While UDI will be required on all products that come under the scope of the EU’s medical device regulations, what is the situation for drug/device combinations? The answer is not simple, and depends on an often-tricky regulatory assessment.
While UDI will be required on all products that come under the scope of the EU’s medical device regulations, what is the situation for drug/device combinations? The answer is not simple, and depends on an often-tricky regulatory assessment.
In this blog, we share our insights and experiences to help companies build quality, scalability, and flexibility into their regulatory writing. We hope you find it insightful. For questions, please contact info@criterionedge.com.
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