Webinar | Impact of New Medical Device EU Regulation (MDR) on the Development of Drug-Device Combination Products
2023-06-29 · 16:00 - 17:00
The European Commission announced on 26 May 2021 the adoption of Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), entailing big changes for manufacturers, for whom bringing Medical Devices to the market is a challenging process.
Among the new information provided in the MDR, additional and more detailed requirements regarding Drug-Device Combination Products have also been established.
- Overview of the changes from MDD to MDR, including new timelines, transition period legacy devices, and Article 117 on DDCs.
- Types of DDC products
- Requirements for non-integral DDCs (Compatibility and Safety between MD and Drug product)
- Requirements for integral DDCs (Notified Body opinion process and timelines)
- Clinical investigations with DDCs
In this webinar, Veristat Regulatory experts will discuss the changes between the Medical Devices Directive and the Medical Devices Regulation and highlight the differences between the requirements and procedures for different types of Drug-Device Combination Products under the MDR. The webinar will include a Q&A session with our experts.
Further Information: www.veristat.com/events/topra-webinar...