This presentation at the 2022 Nelson Labs Virtual Symposium will provide a comprehensive overview of the considerations regarding biological risks associated with primary packaging materials for CE marking of combination products. As the regulatory landscape evolves, understanding the biological risks posed by packaging materials is crucial for ensuring the safety and compliance of combination products.
Participants will gain insights into the specific requirements for assessing and mitigating biological risks to achieve CE marking. The presentation will delve into the regulatory background, highlighting the key criteria and standards that must be met for combination products. This includes understanding the significance of biological risk assessments and the methodologies used to evaluate potential hazards posed by primary packaging materials.
Additionally, the session will address the unique challenges faced by combination products that fall under Article 117 of the Medical Device Regulation (MDR). These products require a Notified Body Opinion (NBOp) as part of the regulatory approval process. The presentation will provide an in-depth discussion of the regulatory requirements, common pitfalls, and best practices for navigating the NBOp process.
Attendees will learn about the critical factors that influence the biological risk assessment of combination products, from initial material selection to final regulatory submission. The session aims to equip professionals with the knowledge needed to ensure their products meet the stringent safety and regulatory standards required for CE marking.
This presentation is essential for professionals involved in the development, regulatory compliance, and quality assurance of combination products. By attending, participants will gain valuable insights into managing biological risks and successfully navigating the regulatory landscape for CE marking, ensuring their products are safe, effective, and compliant with current regulations.