ICON and Simon-Kucher & Partners

Adopt an integrated regulatory and commercial portfolio assessment under MDR and IVDR

The new European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) will require manufacturers to make significant changes in product development, data reporting, and quality assurance. As a result, device manufacturers can expect higher costs and longer timelines for developing new products, as well as costly new clinical monitoring and evidence generation to recertify many existing products. Adapting will take time, funding and effort – making it critical that device manufacturers start now.

To assist you through the process, we have joined forces with Simon-Kucher & Partners to help you prioritise your medical device product portfolio. As device developers prepare for the new regulations, our experts will review regulatory requirements to ensure compliance of both new and existing products, in addition to assessing the commercial contribution of individual products within the portfolio. Start the conversation to discover answers to these key questions:

• Which on-market products are impacted?
• What is the investment required for recertification of the on-market products?
• What is the profit potential for products subject to(re)certification?
• What is the role of the on-market/pipeline products within the portfolio?
• What products should be earmarked for recertification?