This guideline describes the information that should be presented in the quality part of a marketing authorisation dossier for a medicinal product when it is used with a medical device.

This guideline focuses on product-specific quality aspects of a medical device (integral, co-packaged or separately-obtained and referenced in the product information) that may have an impact on the quality, safety and efficacy of a medicinal product.

This guideline should be read in conjunction with the Q&A on the implementation of the Medical
Device Regulation
.

 

This guideline describes the information that should be presented in the Quality part of a marketing authorisation dossier for a medicinal product when it is used with a medical device, or device part, and submitted in accordance with Directive 2001/83/EC and/or Regulation (EC) 726/2004. This guideline focuses on product-specific quality aspects of a medical device, or device part, that may have an impact on the quality, safety and/or efficacy (and hence overall benefit/risk determination) of a medicinal product.
This guideline applies in the following cases:
• Medicinal products where the medical device and/or device part and the medicinal product form an integral product that is not reusable (hereafter called integral) and where the action of the medicinal product is principal,
• Medicinal products placed on the market by the Marketing Authorisation Holder (MAH), where the medical device is packed together with the medicinal product (hereafter called co-packaged),
or
• Medicinal products, where the product information refers to a specific medical device to be used with the medicinal product, and the medical device is obtained separately by the user of the medicinal product (hereafter called referenced).

 

Guideline on quality documentation for medicinal products when used with a medical device