Oct 11, 2011

The Global Harmonization Task Force (GHTF) is seeking comment on a recently issued proposal to establish a global conformity assessment system with uniform obligations for medical device manufacturers and regulators from market to market.

The proposal entails conformity assessments that are commensurately more rigorous from devices with low-risk classifications (Class A) to those with highest-risk classifications (Class D). Device classification should also determine the degree to which regulatory authorities or conformity assessment bodies oversee manufacturers’ compliance claims, according to the GHTF.

Components of conformity assessment identified in the proposal include quality management systems, post-market surveillance systems, device registration.

  • Under quality system requirements, the GHTF notes that in some markets, regulators allow manufacturers to exclude design and development controls and instead utilize type examination. Under this method, the manufacturer sends a representative unit of its device along with technical documentation to a regulator or conformity assessment body for a comprehensive examination to determine compliance with Essential Principles of Safety and Performance of Medical Devices. The GHTF is specifically seeking comment on whether to eliminate the option of using type examinations. “Quality management systems are preferred because they implement a full cycle of design and development controls to ensure that medical devices comply with the relevant Essential Principles of safety and performance,” states the GHTF proposal.
  • In terms of post-market surveillance systems, the GHTF proposal recommends a process covering complaint handling, post-market vigilance reporting as well as corrective and preventative actions. Post-market surveillance systems should be put in place prior to commercialization of a device.
  • Manufacturers are responsible for creating summary technical documentation to support their compliance claims, and regulators or conformity assessment bodies are responsible for evaluating whether that documentation supports manufacturers’ claims of conformity safety and performance principles.
  • Declarations of conformity by device manufacturers must include information such as attestations of compliance with safety and performance principles; applicable Global Medical Device Nomenclature codes; device classification based on Principles of Medical Devices Classification; and which conformity assessment elements have been applied to the device.
  • Registration of manufacturers and their devices is the responsibility of regulatory authorities, as is maintenance of registries.

Finally, the GHTF proposal emphasizes that conformity assessments must be tied more closely to device classifications. The entity suggests a four-tier classification based on risk, with each class of device assigned conformity assessment elements appropriate to the level of risk it poses to patients and users.


  • Stewart Eisenhart