Risk Classification Rules

Regulatory control of medical products should be proportionate to the risk they pose to public health. IVD medical devices are low risk compared to medicines but for some devices an incorrect result (false positive or false negative) is a risk to individual or public health.

Medical devices are classified by risk and the product classification informs the regulatory process, where high risk devices are subjected to more stringent regulatory control than low risk products that pose little or no danger to public health. The Global Harmonization Task Force recommend a four tier system and this used by WHO and a some National Regulatory Authorities.

The rules by which IVD medical devices are assigned to the classification tiers vary and products may be assigned to different risks categories in different countries. Adoption of a standardised set of rules for Africa would greatly facilitate harmonisation activities. For products to have the same risk classification across the region and would reduce the costs and delays associated with registering products in multiple countries in the region.

©2016 Pan African Harmonisation Working Party
Improving Access to Affordable Diagnostics