Manufacturers shall provide formal declarations to confirm key aspects of medical device composition, safety, and regulatory compliance.
The Declaration Pack Template provides a consolidated, structured framework that brings all essential declarations into a single, cohesive set. It includes:
- Declaration confirming whether the device contains metabolically active drugs, animal-derived materials, or human tissues, blood, or derivatives
- Declaration confirming the absence or presence of carcinogenic, mutagenic, or toxic to reproduction (CMR) substances
- Declaration confirming whether the device contains substances intended to be absorbed or dispersed in the human body
- Declaration confirming the absence or presence of human or animal tissues, cells, or their derivatives
In line with Regulation (EU) 2017/745 Annex I, these declarations form an integral part of technical documentation. Developed by experienced regulatory professionals, this template standardises documentation, ensures consistency across declarations, and supports clear confirmation of the conformity of relevant substances and materials. It provides manufacturers with a practical and efficient solution to streamline documentation while maintaining alignment with regulatory expectations.
Price: $100
