How to Register and Maintain Various Types of Combination Products in the USA and EU

Any understanding of the regulatory aspect concerning combination products in the EU is incomplete without a reference to the compromise it reached in September 2016 through its two major legislative organs, the European Commission and the European Council. Relating to medical devices and invitro diagnostic (IVD) devices; this compromise, reached as many as four years after a deal was made, is a regulatory landmark.

It empowers the EMA to now assess and authorize high risk combination devices, such as implants. Formulated to replace the existing EU legislation on medical devices and in-vitro diagnostics, this update brings in greater uniformity and consistency in the assessment and approval process of high risk combination devices across the EU.

Combination Products in the USA and EU