The EU's new medtech regulations introduce much more comprehensive post-market clinical follow-up requirements for device and diagnostics companies. What do they entail, and why are there problems in understanding what will be required? Consultant Sarah Sorrel offers insights in an interview with Medtech Insight.
Post-market clinical follow-up (PMCF) is a relatively new requirement for the EU medtech sector. It is detailed for the first time in the EU's new Medical Device and IVD Regulations.
In this interview, Sarah Sorrel, a leading EU expert and consultant on clinical data issues, discusses with Medtech Insight what...