In an interview with a clinical data expert and consultant Sarah Sorrel by Medtech Insight, Sorrel reveals several critical pieces of information. Vague terminology in the new post-market clinical follow-up (PMCF) requirements for device and diagnostics companies based on the new medtech regulations needs to be cleared up. This needs to be completed urgently so companies can begin the long process of designing, getting approval for, and implementing the new clinical studies. The new PMCF requirements have been applied to ensure safety in products, namely high-risk products, so the strictness of the new regulations is justified. Investigator-sponsored studies may be rejected by notified bodies based on inadequate testing protocols.