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Veristat and TOPRA hosted a webinar on the topic: Impact of New EU Regulations on the Development of Medical Devices and Drug Combination Products
What You Will Learn
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.
Meet the Speakers
Xavier Luria, MD
Vice President, Regulatory Affairs Europe, Veristat
Xavier Luria, MD, is responsible for providing strategic and implementation counsel across the spectrum of global regulatory and pharmacovigilance services for drugs, IVDs, and medical devices. Levering his deep expertise, Dr. Luria drives productive communication with health authorities and associated meetings and submissions, along with overseeing the development of impeccable project regulatory documentation and safety reporting.
Dr. Luria has nearly a decade of experience offering regulatory consulting within the industry, 7 years of experience working as Head of Safety and Efficacy of Medicines at the European Medicines Agency (EMA), and spent the prior 18 years in the pharmaceutical industry.
In addition to Dr. Luria’s specialty in internal medicine, and pharmaceutical medicine and biostatistics (University Autonomous Barcelona), he has developed expertise in several specific therapeutic areas, carried out postgraduate qualification in clinical pharmacology, drug development, and regulation (Tufts University School of Medicine, Boston), and he is a recognized expert on regulatory systems and benefit-risk assessment (modeling, development, and methodologies).
Andrea Larrañaga ,
Associate Manager, Regulatory Affairs, Veristat
Andrea Larrañaga is a Biomedical Engineer (2018 Navarra University-Tecnun, Faculty of Engineering) and earned a master’s degree in biomedical engineering with a specialization in Medical Device Design from the University of Groningen (2020). Andrea is an Associate Manager, Regulatory Affairs, in the MD/ IVD department at Veristat. She has experience in Medical Device/In Vitro Diagnostics design and development and was previously involved in R&D projects related to fluid dynamics, rheology, CAD design, and CT signal post-processing before focusing on the regulatory field.
Laura Ocaña,
Associate Regulatory Affairs Strategist
Laura Ocaña than 14 years of experience in the Pharmaceutical Industry in the fields of R&D, Scale-Up, and Industrialization of Medical Devices, Pharmaceuticals, and Food Supplements, and is involved in developing projects as a Scientific Advisor. Laura is a Biologist (2001, University of Barcelona, Faculty of Biology) and earned a master’s degree in Cell Biology (2008, University of Barcelona, Faculty of Biology). She is currently an Associate Regulatory Affairs Strategist in the MD/IVD Department at Veristat, and possesses a strong technical and scientific background, with broad knowledge in non-clinical research, mainly in safety and efficacy studies.
Gemma Dorrego
Regulatory Affairs Specialist
Gemma Dorrego is a Biological Systems Engineer (2019, Polytechnic University of Catalonia) and earned a master’s degree in biomedical engineering (2021, University of Zaragoza). She is currently a Regulatory Affairs Specialist at Veristat. Prior to joining Veristat, Gemma participated in R&D projects involving molecular biology, cell cultures, and biomaterials. Most recently, she has been involved in the revision of Technical Documentation, and in regulatory strategic analysis and roadmaps for the development of medical devices and in vitro diagnostic medical devices.
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