EU MDR Article 117 & the Combination Product Pathway
What manufacturers of drug-device combination products need to know about Notified Body Opinion under EU MDR — and how to prepare submission-ready evidence.
Regulatory developments, technical perspectives, and commentary on the issues shaping global MedTech today — written by the Credas team and our network of experts.
We’re curating a series of regulatory analyses, technical deep-dives, and case studies — covering EU MDR, US FDA, SaMD, AI medical devices, and APAC market access. Subscribe to our LinkedIn page to be notified when we publish.
A preview of the topics our team will be covering in the months ahead — drawn directly from the engagements we’re running with clients across the globe.
What manufacturers of drug-device combination products need to know about Notified Body Opinion under EU MDR — and how to prepare submission-ready evidence.
Navigating the intersection between the AI Act, EU MDR, and ISO 42001 for AI-enabled medical devices entering the European market.
Why Singapore offers the strongest regulatory foundation for MedTech companies entering Asia Pacific — and how to structure your incorporation correctly.
How to leverage your existing ISO 13485 QMS to build an audit-ready MDSAP programme covering Australia, Brazil, Canada, Japan, and the United States.
Lessons from notified body reviews — the most common gaps in CER documentation and how to address them before submission.
The full pathway from gap assessment through dossier submission, performance evaluation, and post-prequalification commitments.
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