Through theMedical Device Regulation (MDR) and new version of ISO 14155, the regulatory landscape for clinical investigations with medical devices will significantly change. In contrast with previous regulations, all PMCF clinical investigations will have to be conducted in compliance with the ISO 14155 standard. Although some PMCF investigations may be exempted from a number of requirements, the basic necessities remain applicable, such as implementing written quality procedures, monitoring and document management.

The MDR specifies that clinical investigations should be in line with ISO 14155:2011 on good clinical practice (MDR (64): p. 9) and that sponsors should provide evidence that clinical investigations are conducted in line with good clinical practice. In addition, under the MDR both pre- and post-market clinical studies count as a clinical investigation, which extends the requirement to comply with good clinical practice to post-market trials, both interventional and observational types.

Although the COVID-19 pandemic has delayed the implementation date, now is still the time to prepare your organization for the MDR and ISO14155 regulations.

In this white paper, we discuss how the following will be impacted:

  1. Quality procedures
  2. Clinical investigation plans
  3. Informed consent
  4. Data collection and processing
  5. Data monitoring and document management
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