Impact Of New EU Regulations On The Development Of Medical Devices And Drug Combination Products

In May 2021, the European Commission announced the adoption of Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), which entailed big changes for manufacturers, for whom bringing medical devices to the market is challenging. Additional and more detailed requirements regarding drug-device combination products were also established among the new information provided in the MDR.

To gain a better understanding of these changes, the following regulatory experts from Veristat recently discussed the impacts of the Medical Devices Directive and the Medical Devices Regulation:

• Xavier Luria, MD, Vice President, Regulatory Affairs Europe, Veristat
• Andrea Larrañaga, Associate Manager, Regulatory Affairs, Veristat
• Laura Ocaña, Associate Regulatory Affairs Strategist
• Gemma Dorrego, Regulatory Affairs Specialist

Watch this webinar as speakers delve into the differences between the requirements and procedures for different types of drug-device combination products under the MDR.