Combination Products

Primary Mode of Action (PMOA)

Define whether your product is primarily a medical device or a medicinal product to follow the appropriate regulatory pathway.  

Determine the appropriate pathway  

If the medicinal product is ancillary, your combination product should be developed in compliance with Regulation (EU) 2017/745 (Medical device regulation). If the medicinal product is principle, it is regulated under  the Medicinal Product Directive (Directive 2001/83/EC). 

Regulatory pathway for medical device combination products. 

The notified body must ask the EMA for a scientific opinion on the quality, safety and suitability of the excipient in three cases:  

• if the excipient is derived from human blood or plasma; 
•  if it has been previously assessed by the EMA; 
•  if it falls within the mandatory scope of the centralized procedure.  
  
  

 For other substances, the notified body may seek the opinion of the national competent authority or the EMA, e.g. in cases where the EMA has already assessed a medicine containing the same medicinal substance. 

Regulatory pathway for medicinal combination products. 

Different types of medicinal products. 

Integrated/co-packaged medicinal products: 

 When a complex product is classified as a medicinal product, specific regulations must be followed depending on its type. 

 A guide to the regulatory process. The flowchart below outlines the necessary steps to obtain all required documents and quality certificates, based on the guidelines for quality documentation for medicinal products used with a medical device.