Thierry Sirdey (Chair)
Head of the department for medical devices, cosmetics and in vitro diagnostic devices, National Agency for the Safety of Medicines and Health Products (ANSM), France
With a background in polymer chemistry, Thierry began his career in the medical device industry sector where he moved from new product development and production activities to quality and regulatory affairs. He joined the French medical device competent authority in 2005
He has been involved in several groups at European and international levels, and notably for the implementation of medical device regulation on software (European software working group and IMDRF software as medical device group).
Thierry is now the head of the medical device and IVD products directorate in ANSM. He is a French representative at MDCG.
” MDR and IVDR are major milestones for the European regulation of MD and IVD products. It’s a unique opportunity to bring to patients safer, more innovative and more performant medical devices. This new regulatory framework is ambitious and reflects the MD and IVD network.
National competent authorities should play a major role in the success of the implementation of the new regulatory framework. CAMD is the forum to build and to reinforce mutual understanding, best practices sharing and developing training between national agencies.
CAMD Executive group will continue to support the European Commission and MDCG in their activities, by providing proposals and by acting to guarantee a successful implementation of the new regulation.”
Carmen Ruiz-Villar Fernandez-Bravo (Co-Chair)
Head of Medical Devices Department, Spanish Agency for Medicines and Medical Devices (AEMPS), Spain
Carmen, with a background in Pharmacy, a master in medical devices and another in regulatory procedures for medicines, initiated her career in 2003 as a clinical assessor for human medicines at AEMPS. She was also in charge of the coordination of centralized procedures for medicines marketing authorizations and management of the Scientific Advice Unit.
In 2006, she moved to the medical devices Department to the Vigilance and Marketing Surveillance Unit, being responsible for the coordination and management of all the vigilance notifications. During 12 years she was a member of the Vigilance Expert Group and a IMDRF European member for the NCAR program.
In 2015, she worked as a National Expert in Professional Training at the Commission FVO, Santé 5. During this period she performed several audits for Notified Bodies designation.
From the end of 2018, she is acting as the Head of Medical Devices Department at the Spanish Agency, dealing not only with medical devices but also with cosmetics and biocides. She has an active role in the implementation of the new regulation and in the development of the medical devices national legislation. She works on the coordination of the activities for the designation and surveillance of the Spanish notified body under the appointment of the Ministry of Health. She is member of several European working groups as MDCG, CAMD including the Operational Working Group and the IMDFR.
Dr. Helena Dzojic
Head of Department of Medical Devices, the Medical Products Agency, Sweden
Helena holds a PhD in Clinical Immunology from Uppsala University and has nearly five years of research experience within the field of immunotherapy. Since 2011 she has held the role of Head of the Department for Medical Devices at the Medical Products Agency in Sweden where she has had several roles since 2007. Helena also has broad experience in the field of regulation and market surveillance of medical devices.
Furthermore, she has experience of working in several EU working groups such as MD IVD, MD Compliance & Enforcement (COEN) WG, Medical Devices Experts Group (MDEG) and MD Regulatory Committee. She is also member of The Market Surveillance Council, a national coordination body for market surveillance in Sweden.
Dr. Wolfgang Lauer
Head of the division “Medical Devices”, BfArM, Germany
Wolfgang is the Head of the division “Medical Devices” of the Federal Institute for Drugs and Medical Devices (BfArM) in Germany.
He studied Mechanical Engineering at the RWTH Aachen University where he also received his doctoral degree in the field of robotic support systems for surgery. At the Chair of Medical Engineering of the RWTH Aachen University, Wolfgang for several years headed a research group on risk management and ergonomic quality of medical devices before he became Head of the “Medical Devices” Division at BfArM in 2011.
Wolfgang is actively involved in several groups on German and European level with regard to scientific as well as regulatory aspects of medical devices. He has a strong focus on digital health and the respective scientific and regulatory development for medical devices as part of a future digital healthcare environment in Europe.
“The dynamic development in the field of medical devices, mobile technology and digital healthcare will offer fascinating opportunities for our societies, innovators and patients. It will also pose special challenges for regulators, because innovation does not stop at indication, sector and technology boundaries. As competent authorities for medical devices, we play an important role in this context: we support innovation and at the same time ensure that medical devices are safe, effective and available in the European healthcare system.”
Niall MacAleenan
Medical Device Lead, Health Products Regulatory Authority (HPRA), Ireland
Niall is the Medical Device Lead and Clinical Assessment & Policy Manager for medical devices at the Health Products Regulatory Authority (HPRA) in Ireland. At the HPRA he is responsible for coordinating medical device activities with specific operational focus on market surveillance of medical devices, notified body designation & oversight and assessment of clinical investigations and clinical evaluation of medical devices.
Niall is a member of a number of different EU working groups on medical devices including the Medical Device Expert Group (MDEG), the Medical Device Regulatory Committee, the Clinical Investigation and Evaluation Working Group (CIEWG) and the Notified Body Operations Group (NBOG). He is a member of the European delegation to the Management Committee of the International Medical Device Regulators Forum (IMDRF).
Niall is a medical doctor with a broad experience in hospital medicine having completed general professional training in internal medicine. Niall’s clinical research interests included endoscopic screening for gastrointestinal malignancy and antimicrobial resistance patterns for Helicobacter pylori. In addition to his medical degree, Niall also holds a Masters in Business Administration.
Martin Renhardt
Head of Department Pharmaceuticals and Medical Devices, Blood, Tissue and Transplantation, (Sozial Ministerium) Austria