Dr. Helena Dzojic (Chair)
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.
Thierry Sirdey (Co-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 as chief of market surveillance and conformity assessment unit for medical device which scope was enlarged to IVD in 2010.
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).
Deputy director of medical equipment and IVD department from 2012 to 2018, Thierry is now the head of the medical device, IVD and cosmetics 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. Such a regulation needs a strong network among European competent authorities. CAMD Executive group has a major role to play in bringing this network alive, able to support the European Commission and MDCG to guarantee a success for the new regulation implementation.”
“ANSM continues its efforts to improve European collaboration in order to strengthen competent authorities network to raise up the confidence and efficacy on the medical device and IVD European regulatory framework.”
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. 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.
Alexandre Jauniaux
Head of Medical Devices Entity, Health Products Division, DG POST Authorisation, Federal Agency for Medicines and Health Products (AFMPS), Belgium
Alexandre holds a master degree in biology with an orientation in biotechnology. He started his career in 2006 working in private CROs as responsible for the managing of clinical investigation databases.
In 2013, he joined the division of medical devices of the FAMHP as file manager and became more and more experienced in medical devices domain. He became the head of the division in 2016 and started to improve the division by increasing the staff and enhance the internal medical devices expertise. In 2017, the FAMHP took over the IVD responsibilities for which it made sure to increase the internal knowledge in this area.
Furthermore, Alexandre is a member of International Medical Device Regulators Forum (IMDRF), Medical device coordination group (MDCG) and the market surveillance group.
Darek Foit
Director of Expert Activities Department, Medical Devices Section, State Institute for Drug Control (SUKL), Czech Republic
Darek holds doctorate of medicine from the Faculty of Medicine of the J.A. Comenius University in Martin, Slovakia. After his studies, he worked in general surgery at a district hospital. Shortly after attestation, he went into the pharmaceutical industry, where he held various management positions during a more than twenty-year career, including international executive roles both in companies based on research and development of original medicinal products, as well as in generic companies and contract manufacturing. He earned the Master of Business Administration (MBA) degree after successfully completing the International Executive MBA program at the University of Pittsburgh, USA.
As part of his work in the state administration, he held the position of inspector of good clinical practice of the Supervision Section of the State Institute for Drug Control and subsequently started working in the same institution in the field of regulation of medical devices in 2017. After 5 years of successful development of the Medical Devices Department he is focusing now on the clinical evaluation and expert opinions as director of newly established Department of Expert Activities within the Medical Devices Section.
Furthermore, Darek is a deputy member of the Medical Devices Coordination Group (MDCG) on behalf of the Czech Republic.