Post-Market Surveillance

Home Medical Devices Post-Market Surveillance Post Market Surveillance Report (PMSR) and Periodic Safety Update Report (PSUR)

Post Market Surveillance Report (PMSR) and Periodic Safety Update Report (PSUR)

The PMSR or PSUR summarise the results of the analyses of the post-market surveillance data and the conclusions of the benefit-risk determination together with a rationale and description of any preventive and corrective actions taken. In the framework of the post-market surveillance there is the need to prepare a PMSR for class I devices. The report shall be updated when necessary and made available to the competent authority upon request. However, for class IIa, class IIb and class III devices, a PSUR needs to be prepared that must be updated annually (class III and IIb devices) or at least every two years (class IIa devices). In case of implantable and class III devices, the PSUR should also made available in EUDAMED.

  • LITERO prepares PMSRs and PSURs for your devices or device groups according to MDR Article 86 and the corresponding MDCG guidance and forwards it, if applicable, to EUDAMED.
  • Are the conclusions of the PMSR or PSUR regarding performance, benefits and (residual) risks adequately reflected in related documents such as Risk Management, Clinical Evaluation Report (CER), or Instructions for Use? We check your documentation and support you in your process development.
Diagram: Claims

Within the framework of PSUR or PMSR compilation LITERO evaluates the results of the post-market survaillance data.

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