Veristat and TOPRA recently hosted an informative webinar on the topic of the impact of new EU regulations on the development of medical devices and drug combination products. The European Commission's adoption of Regulation (EU) 2017/745, known as the Medical Devices Regulation (MDR), has significantly changed manufacturers' market access process. Additionally, the webinar delved into the updated requirements for Drug-Device Combination Products under the MDR, including timeline changes, transition periods, and Article 117 on DDCs.
During the webinar, Veristat's regulatory experts discussed the transition from the Medical Devices Directive to the Medical Devices Regulation, emphasizing the differences in requirements and procedures for various types of Drug-Device Combination Products.
Topics covered included:
An overview of the changes.
Types of DDC products.
Requirements for non-integral and integral DDCs.
Clinical investigations with DDCs.
Attendees had the opportunity to participate in a Q&A session with our experts, gaining valuable insights.
If you missed the live webinar session, you can still access the on-demand recording and slide presentation assets for a comprehensive understanding of the new EU regulations.
Click here to download the final presentation as a PDF.
Stay informed and stay ahead in navigating the evolving landscape of medical device regulations in Europe.
With extensive experience in regulatory consulting and previous roles at the European Medicines Agency (EMA), Dr. Luria provided strategic guidance in global regulatory and pharmacovigilance services, ensuring compliance and effective communication with health authorities.
Leveraging her background in biomedical engineering, Andrea contributed her regulatory expertise, specifically in the areas of medical device design and development, ensuring adherence to regulatory requirements.
Laura Ocaña, Associate Regulatory Affairs Strategist
With a solid scientific background and over 14 years of experience in the pharmaceutical industry, Laura played a key role in the webinar by sharing her knowledge in R&D, scale-up, and industrialization of medical devices and pharmaceuticals.
Gemma Dorrego Regulatory Affairs Specialist
Gemma's expertise in biological systems engineering and biomedical engineering contributed to the webinar's insightful discussions on technical documentation revision and regulatory strategic analysis for medical device and in vitro diagnostic device development.