Carmen Ruiz-Villar Fernandez-Bravo (Chair)
Deputy Director 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 Deputy Director 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 and the IMDFR.
“In these times, were changes are foreseen for the MDR and IVDR to improve our competitiveness, the voice and influence from the CA in our regulatory system needs to be heard. A creation of a more powerful and strategic CA network coming from the current CAMD best features will help to face these challenges, improve our regulatory framework and achieve our goals as a network.
In a place where many horizontal regulations, as artificial intelligence, European Health Data Space or environmental, are influencing our regulatory framework, an strategic approach form medical devices CA is need to guarantee the presence in our market of safe and innovative devices for our population.
CAMD Executive group will continue to collaborate with the European Commission and MDCG, by presenting our interests and priorities on medical devices to guarantee a coordinate and predictable regulatory framework”
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.”
Jeppe Larsen
Senior Director & Head of Medical Devices at the Danish Medicines Agency, DKMA, Denmark
Jeppe Larsen has served as Senior Director for Medical Devices at the Danish Medicines Agency since 2022, leading a team of more than 50 employees His department is Denmark’s competent authority for MDR and IVDR and the designating authority for Notified Bodies that certify according to the MDR and IVDR
Internationally, Jeppe represents the EU on the IMDRF Management Committee, where he works toward global regulatory harmonization and champions the European model. A particular focus has been AI and digitalization — areas where Denmark is leading efforts, including engagement with the EU’s AI Act.
In 2024, Jeppe also served as Co-chair of the HMA-EMA Big Data Steering Group, nominated to represent the Heads of Medicines Agencies (HMA) and leading the network alongside EMA’s Peter Arlett. The group was tasked with developing and implementing a strategy to harmonize the use of Real World Data in regulatory science and research.
Before joining the Danish Medicines Agency, Jeppe was an Engagement Manager at Implement Consulting Group, specializing in operational excellence. His expertise spans Lean, process optimization, agile operations, project management, and change management—particularly in the life sciences, healthcare, financial services, and public sector
Gwennaelle Even
Deputy Director, Medical Devices and In Vitro Diagnostics Division, ANSM, France
Gwennaelle Even is a pharmacist with over 15 years of experience at ANSM, where she currently serves as Deputy Director of the Medical Devices and In Vitro Diagnostic Devices Division for 7 years. She is involved in different activities supporting the implementation the new EU regulations (MDR/IVDR) in France and shaping national legislation for medical devices and IVDs.
Her career at ANSM includes leadership in clinical and scientific assessment, with a focus on cardiovascular, thrombosis, and oncology products. Gwennaelle actively represents France in European and international regulatory forums, contributing as a member of several MDCG working groups and task forces. She most recently co-leads the JAMS 2.0 project, which aims to strengthen European cooperation in market surveillance. Her work underscores her commitment to collaboration among regulatory authorities to advance public health and innovation.
Niall MacAleenan
Director of Medical Devices, Health Products Regulatory Authority (HPRA), Ireland
Niall is the Director of 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 and international groups on medical devices including the Medical Device Coordination Group (MDCG) and is a member of the Management Committee of the International Medical Device Regulators Forum (IMDRF). He was part of the Irish delegation to the European Council working party during the negotiations of the EU medical device regulations from 2012-2017.
Niall is a medical doctor with a broad experience in hospital medicine having completed general professional training in internal medicine and several years of clinical research. In addition to his medical degree, Niall also holds a Masters in Business Administration.
Dr. Helena Dzojic
Head of Department of Medical Devices, the Medical Products Agency, Sweden
Helena Dzojic holds a PhD in Clinical Immunology from Uppsala University in Sweden. She has worked at the Swedish Medical Products Agency since 2007 and has headed the Medical Device department since 2011.
The agency acts as Sweden’s Competent Authority for medical devices and as a designating authority for notified bodies under the MDR and IVDR. Its remit is broad and expanding, covering regulatory implementation, market surveillance and assignments linked to the AI act, the European Healht Data Space (EHDS) and the NIS2 Directive.
Helena is Sweden’s delegate in the Medical Device Coordination Group (MDCG) and the Committee on Medical Devices. She has long-standing experience from EU working groups and is strongly engaged in EU cooperation.