You need to ensure EU Medical Device Regulation (MDR) compliance, but you also want to avoid the cost and time of unnecessary clinical investigations. Luckily, not every implantable and class III device needs clinical investigation! There are four main exemptions to the clinical investigation mandate under MDR, all of which are thoroughly detailed in our white paper.
Download it now to learn:
- The four cases exempt from the requirement to perform clinical investigations
- Criteria for clinical investigation exemptions
- Data necessary to justify claims of device equivalence
- The four levels of data access used to determine equivalence
When You Need to Advance Your Regulatory Strategies and Submissions, It Takes Avania.
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