Feb 14, 2019

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Good Clinical Practice (GCP) must be adhered to by medical device companies conducting clinical investigations for their products.
  • GCP requirements make exceptions for software as a medical device (SaMD) for which some developers may qualify.
  • Besides GCP, additional standards such as ISO 14155 may apply to clinical studies for medical devices.

Medical device manufacturers should ensure compliance to Good Clinical Practice (GCP) as they undertake clinical investigations to meet regulatory requirements.

The GCP International Standard addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess safety and/or performance of devices for regulatory purposes.

GCP principles and requirements

The principles set forth in this International Standard also apply to all other clinical investigations, and should be followed as far as possible, considering the nature of the clinical investigation and the requirements of national regulations.

The GCP International Standard specifies general requirements intended to:

  • Protect the rights, safety and well-being of human subjects,
  • Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
  • Define the responsibilities of the sponsor and principal investigator, and
  • Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

However, GCP does not apply to IVD devices.

Considerations for Software as a Medical Device (SaMD)

Developers of software as a medical device (SaMD) may qualify their products for exemption from GCP requirements because SaMD typically has indirect contact with patients. However, it is required to demonstrate:

  • Analytical validity in terms of SaMD’s output being accurate for a given input;
  • Scientific validity (SaMD’s output is associated with intended clinical condition or physiological state) where appropriate;
  • Clinical performance whereby SaMD’s output yields clinically meaningful association to the target user or patient.

Beyond GCP: Related standards and requirements for clinical investigations

On a related note, medical device manufacturers and clinical trial sponsors should also determine whether other standards besides GCP apply to their clinical investigations.

Aleksandra Klimaszweski is Manager of Clinical Affairs at Emergo Clinical BV.

Additional medical device clinical resources from Emergo by UL:

  • GCP and ISO 14155 compliance consulting for medical device companies
  • Medical device clinical trial design and protocol development support
  • Medical device clinical trial management and monitoring assistance
  • European post-market clinical follow-up (PMCF) study support
  • Video overview: Clinical evaluation reports (CER) for Europe