A Comprehensive Guide on How and When to Conduct PMCF Activities for Initial CE Mark Certification and Re-Certification
You want your medical device to perform well in every target market, but even the most well-executed pre-market studies can’t predict every facet of a full device launch. To get a complete view of your device’s risks and benefits — and to meet the EU’s Medical Device Regulation (EU MDR) requirements — you might need to conduct post-market surveillance activities, like post-market clinical follow-up (PMCF).
But what counts as PMCF? What purpose does it really serve? Do you always need it? And, perhaps most importantly, how do you accomplish it?
Our white paper, “Post-Market Clinical Follow-Up (PMCF): Best Practices for Success,” answers these questions and more, giving you all the information and tools you need to advance your medical device with thorough, high-quality data. Download it now to explore:
- The basics of clinical evaluation
- The importance of PMCF
- When to conduct PMCF activities
- 3 best practices for PMCF success
- The pros and cons of different data collection methods
- Examples of successful PMCF
When you need to advance your PMCF activities, It Takes Avania.