Interview by Amanda Maxwell
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 PMCF will entail. Sorrel, president of MedPass International, also addresses how slow implementation of the new regulations is making it difficult for manufacturers to put post-market plans into place and to leverage the potential value of PMCF to help obtain recertification of devices under the new regulations.
Sorrel previewed some of the themes that will be highlighted next month at the 3rd European Symposium on New Medical Device Regulations, in Brussels, where she will be speaking about the challenges manufacturers are facing.
Sarah Sorrel: Without the delegating acts, it is not entirely clear when PMCF will be mandatory under the MDR. This is a problem for manufacturers who need to plan now and to decide whether the cost of PMCF would warrant taking certain products off the market in view of the increased cost of compliance.
There is a new safety reporting requirement for all devices (except class I) called the Periodic Safety Update Report, PSUR. The PSURs are required at least every year for class III devices and class IIb implantables and at least every two years for class IIa devices and class IIb non-implantables. According to the regulation, the PSUR is based on the PMCF, so in theory a PMCF would be required for all of these classes of device. On the other hand, elsewhere in the regulation, it is stated that some products can be exempt from PMCF if duly justified. Clarification is needed urgently to address this apparent contradiction.