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Updated IMDRF guidance on PMCF studies

Wiebe Postma, PhD Sr. Clinical Consultant, clinical evaluation, investigation & CRO
On 20 May the IMDRF posted an updated guidance on Post-Market Clinical Follow-up (PMCF). Guidance IMDRF/MDCE WG/N65 FINAL:2021 updates the former GHTF document on PMCF which dates back to 2010 (GHTF/SG5/N4:2010).

The document is intended to provide guidance on the design, implementation and appropriate use of PMCF studies. The scope covers:

  • when a PMCF study is indicated;
  • the objectives of PMCF studies;
  • design and implementation of PMCF studies;
  • the use of information from PMCF studies.

The document also contains references to the applicable IMDRF guidance documents on clinical evidence, clinical evaluation, and clinical investigation, as well as the applicable international standards including ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good Clinical Practice and ISO 14971:2019 Medical devices - Application of risk management to medical devices.

There are no major changes compared to the previous GHTF document. Some more guidance is provided on study design. Regarding the use of information from PMCF studies, a link is made to potential corrective or preventive actions. It is now also stated that PMCF data can be used to:

  • become part of premarket clinical evidence, or supplementary data for next generation or similar technologies when applying for marketing authorization.
  • develop objective performance criteria and performance goals;
  • form control/comparison groups.

The main new additions consist of three new informative appendices:

Appendix A provides examples of clinical experience data sources for PMCF studies. Data generated from real world clinical experience is an important data source that should be considered for PMCF studies. Examples given include registries, medical records and surveys.

Appendix B concerns considerations for using clinical experience data for PMCF studies. This includes legal and ethical considerations, study design and data quality. Some practical principles are given that should be considered to ensure quality of the data source.

Appendix C discusses potential biases and confounding in PMCF studies as well as controlling methods.

In conclusion, the guidance can be a useful supportive document for the design and execution of PMCF studies and the use of PMCF data. The appendices in particular provide insightful examples and practical guidance that cannot be found in the MDR or ISO 14155 standard. If you would like to read the guidance yourself (its only 17 pages), you can find it here.

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