Module 17 2024

05/12/2024

Chapter 14: Alternative Routes to Market

The following devices would only be eligible for Route 2: • Medical devices that utilize animal tissues and their derivatives • Medicinal products that include a medical device in the secondary packaging of the medicinal product (i.e. co-packaged) • Companion diagnostics

The Organisation for Professionals in Regulatory Affairs

103

103

Chapter 14: Alternative Routes to Market

Next Steps  This proposed framework is still a draft and in consultation, and the final version would come into force simultaneously with the future core regulations, which aim to be in force in 2025.  The operational aspects of this framework, including who the documentation is submitted to, who reviews the documentation, who performs the subsequent post market surveillance and change assessment, and the requirements for these assessments, are being developed under discussions with industry, designated UK Approved Bodies. These are significant issues and require full agreement. The decisions in this area will significantly impact the success and feasibility of this proposed process.  Market access via this proposed international recognition process will only be formally granted once the future core regulations are in force, and the proposed framework may be updated based on these activities.

The Organisation for Professionals in Regulatory Affairs

104

104

52