Combination Products

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.*

Challenges

Combination products are Class III devices which require a thorough assessment procedure. Because of their complexity and risk, not all consultancy companies and Notified Bodies can assess combination products, which may be subject to additional directives 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 consultancy company is critical, so that you can have confidence in their assessments and collaboration with other organizations. Gemar has significant experience with various families of combination products and can call on experts in biological and viral safety when necessary to certify products.

 

Advantages

Gemar is recognized to assess Active Implantable Medical Devices and has significant experience certifying a wide range of devices for CE Marking, often in conjunction with ISO 13485CMDCAS, mock FDA inspection and other audits, to save the time and cost of multiple audits

 To discuss this service, please Contact us to see how we may be able to assist you.