Although the notion of Combination Products under U.S regulations can be broad, the EU medical directives cover essentially three configurations:
- Medical device incorporating a drug
- Medical device incorporating a human blood derivative
- Medical device using a material of animal origin
According to one survey, an estimated 30% of products under development are such "combo" products. The convergence of drugs/biologics and devices brings a host of regulatory challenges.*
Combination products are Class 3 devices which require a thorough assessment procedure. Because of their complexity and risk, not all Notified Bodies can assess combination products, which may be subject to additional requierements if devices incorporate a substance of animal origin (if considered a risk of transmissible spongiform encephalopathies) or human blood derivatives.
Determining a device's status, whether it is a drug or medical device, depends upon its primary mode of action. This can be a difficult determination involving not just the Notified Body, but also the Competent Authority and the European Commission.
Your selection of a credible, respected Notified Body is critical, so that you can have confidence in their assessments and collaboration with other organizations. GMED has significant experience with various families of combination products and can call on experts in biological and viral safety when necessary to certify products.
*Source: Stephen Ritcher, Ph.D, Combination Products: Navigating Two FDA Quality Systems, PharmaManufacturing.com: accessed online on March 28, 2010