The Committee for Human Medicinal Products (CHMP) Concept Paper on Quality Requirements of Medicinal Products Containing a Device Component
Annex 1 of the Directive 2001/83/EC, requires that details are provided for the medical devices with the medicinal product. However, given the wide diversity of devices supplied with medicinal products and continuous technological developments, together with the differences in medical device and medicinal product legislation, the data supplied in the dossiers of the marketing authorisation applications has found to be inconsistent and often incomplete.
The Committee for Human Medicinal Products (CHMP) have published their concept paper on developing a guideline on Quality requirements of medicinal products containing a device component for delivery or use of the medicinal product. The concept paper addresses the need for development of a guideline on dossier requirements for medical devices that are supplied along with medicinal products where a device is necessary for administration or localisation (site-specific delivery) of the medicinal product.