6 Important PMCF Pitfalls You Should Avoid in the EU MDR Era
Six Important PMCF Mistakes Medical Device Manufacturers Should Avoid
According to the new European Medical Device Regulation (EU MDR), Post-Market Surveillance (PMS) activities are crucial for identifying and investigating potential residual risks of medical devices after they have been taken to market. Such risks should be tracked and assessed through systematic Post-Market Clinical Followup (PMCF).
Manufacturers with devices which previously obtained compliance based on equivalence with another device already on the market must conduct proactive PMCF studies to reassess their residual risks to ensure compliance.
While PMCF will increase costs of PMS in the short term, it can also be seen as an opportunity for alignment of processes across the operational portfolio in the long term. Proactive PMCF system can be leveraged to not only gather data for compliance, but also to gain more comprehensive market insights and product marketing claims.
In this Slide Deck, we outline 6 pitfalls to avoid when conducting your PMCF activities including
- Interpretation of Terms and Requirements
- Study Design
- Study Subjects
- Patient Recruitment
- Communication with Notified Bodies
- Managing PMCF on Paper versus in the Cloud
We hope that you will enjoy this Slide Deck. If you have any questions or feedback, please feel free to contact us at hello@climedo.de.