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. LNE/G-MED 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