A proposed guidance document from the Global Harmonization Task Force (GHTF) recommends standardizing conformity assessments for four medical device classes. The recommendations take into account the relative potential of each class to cause user or patient harm.
Released Oct. 3, the non-binding GHTF document, Principles of Conformity Assessment for Medical Devices, is presented as a series of recommendations directed toward regulatory agencies globally. With the goal of harmonizing documentation and procedures, GHTF aims to eliminate differences between regulatory jurisdictions, decrease the cost of attaining compliance and allow patients earlier access to new technologies and treatments.
The document “seeks to strike a balance between the responsibilities of regulatory agencies to safeguard the health of their citizens and their obligations to avoid placing unnecessary burdens upon the regulated industry,” the authors wrote.
Within the guidance, the GHTF recommends five conformity-assessment elements that regulatory agencies may make available to the consumer: a quality management system, a system for post-market surveillance, summary technical documentation, a declaration of conformity and the registration of manufacturers and their medical devices by the regulatory agency.
“A manufacturer needs to demonstrate its ability to provide medical devices that consistently meet both customer and regulatory requirement,” the authors wrote. “Manufacturers demonstrate compliance through an established and effectively implemented quality management system that meets the regulatory requirements.”
The GHTF encourages the use of four device classes—Classes A, B, C and D—based on their level of risk to users or patients. Class A represents the least amount of risk. Conformity-assessment charts for each of the device classes are available in the guidance.