Clinical Evaluation and Post-Market Surveillance

Clinical Evaluation and Post-Market Surveillance

EU MDR 2017/745 Clinical Evaluation and Post‑Market Requirements

The EU MDR 2017/745 places strong emphasis on continuous evidence of safety and performance throughout the lifecycle of a medical device. Beyond initial CE marking, manufacturers must maintain ongoing documentation and surveillance to demonstrate compliance. Key elements include:

Clinical Evaluation Reports (CERs)

  • CERs provide documented evidence that a device achieves its intended purpose safely and effectively.
  • They include analysis of clinical data, literature reviews, and post‑market information.
  • A CER is required for initial CE marking and must be updated regularly to reflect new data.


Post‑Market Surveillance (PMS)

  • PMS is a proactive system for monitoring device performance once it is on the market.
  • It involves collecting, analyzing, and responding to data on safety, quality, and usability.
  • PMS ensures early detection of risks and supports continuous improvement.


Periodic Safety Update Reports (PSUR)

  • PSURs are mandatory for Class IIa, IIb, and III devices.
  • They summarize PMS findings, clinical data, and risk‑benefit evaluations over a defined period.
  • These reports must be submitted to notified bodies and authorities to confirm ongoing compliance.


Summary of Safety and Clinical Performance (SSCP)

  • SSCPs provide transparent information for healthcare professionals and patients.
  • They outline device safety, clinical performance, and residual risks in a clear, accessible format.
  • SSCPs are published on EUDAMED to enhance public trust and regulatory transparency.


Post‑Market Clinical Follow‑Up (PMCF)

  • PMCF is an extension of PMS focused on gathering long‑term clinical evidence.
  • It involves studies, registries, or surveys to confirm that safety and performance remain consistent in real‑world use.
  • PMCF data feeds back into CERs, PMS, and PSURs, ensuring a continuous compliance cycle.


Together, these requirements form the backbone of EU MDR lifecycle compliance, ensuring that medical devices are not only safe and effective at launch but remain so throughout their market presence.