- EU MDR 2017/745 Compliant Solutions
Expert PMCF Survey Services for Medical Device Regulatory Compliance
Bridge clinical data gaps and maintain CE marking with scientifically robust, end-to-end Post-Market Clinical Follow-up survey solutions designed for Notified Body approval.
- Level 4 Clinical Evidence
- 100% NB Acceptance Rate
- ISO 14155 Compliant
Trusted by leading medical device manufacturers
- BSI Certified
- TÜV SÜD Partner
- DNV Approved
Overview
What is Post-Market Clinical Follow-up?
Post-Market Clinical Follow-up (PMCF) is a critical component of a manufacturer’s post-market surveillance obligations under EU MDR (2017/745) and IVDR (2017/746).
PMCF activities are designed to proactively collect and evaluate clinical data on a CE-marked device to confirm ongoing safety, performance, and clinical benefit throughout its lifecycle.
Sora Lifesciences supports medical device and diagnostics manufacturers in designing, executing, and reporting PMCF surveys that are scientifically robust, regulator-ready, and aligned with notified body expectations.
Why PMCF Is Required Under MDR/IVDR
Under MDR/IVDR, manufacturers must demonstrate that:
- The device continues to perform as intended in real-world clinical use
- Identified and residual risks remain acceptable
- No new safety signals or performance gaps emerge post-commercialization
- Clinical evidence remains current, relevant, and sufficient
Important: For many devices (especially legacy devices), pre-market clinical evidence alone is no longer sufficient. Notified bodies increasingly expect active PMCF data generation, not just literature updates.