The European Medicines Agency issued a draft guideline on quality requirements for combination devices, opening the guidance up to a three-month public consultation.
The guideline, which applies to devices required for administering, dosing or using medications, is meant to improve the consistency and transparency of information included in regulatory submissions for those products. It also includes a proposed template for notified body opinions on device conformity to general safety and performance regulations.
Specifically, it details device information sponsors need to include in their initial marketing authorization applications and during their products’ lifecycle, such as a description of the manufacturing process, the container closure system, and functional performance and stability studies. For example, sponsors should discuss and justify the suitability of the device for the particular drug product and perform interaction studies using a risk-based approach.
If the combination product includes a drug product intended to be sterile, the device’s sterility should be verified by referring to its CE certificate. Maintenance of sterility throughout the product’s use, as well as the final medicinal product’s shelf-life, should also be documented, the guideline says.
Read the full draft guidance here: www.fdanews.com/06-04-19-EMA.pdf. — James Miessler