Through the Medical 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 Post-Market Clinical Follow-up (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 (MDR Annex XV Chapter III Point 6: p. 172). 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.
In addition, Annex I of the new ISO 14155 describes the clinical development stages of medical devices, including the applicability of the standard to every specific stage. For post-market observational studies, possible exemptions are indicated for device accountability, labeling for clinical investigations, need for an Investigator Brochure, reporting to regulatory authorities, full informed consent, and CVs of members of the investigation site team.
Although the COVID-19 pandemic has delayed the implementation date, now is still the time to prepare for compliance with this updated set of regulations. In this white paper, we discuss how the following will be impacted:
- Quality procedures
- Clinical investigation plans
- Informed consent
- Data collection and processing
- Data monitoring and document management
Prepare your organization for the MDR and ISO14155 updates with this white paper. Fill out the form below to download your copy!