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Medical devices notified bodies : MDR challenges and gap analysis
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A regulamentação dos dispositivos médicos (DM) é fundamental para garantir a segurança e a qualidade nos cuidados de saúde. O Regulamento sobre Dispositivos Médicos (RDM) da União Europeia alicerça estes objectivos, atribuindo uma responsabilidade significativa aos Organismos Notificados (ON) como entidades independentes encarregues de avaliar a conformidade e permitir o acesso ao mercado. Esta tese investiga o papel dos ON na indústria dos DM e a sua influência na acessibilidade ao mercado, na segurança e possível impacto na inovação. Os principais objectivos incluem a análise da capacidade dos ON para satisfazerem as exigências do RDM e gerirem eficazmente o processo de certificação. O estudo identifica lacunas entre a designação dos ON e as diversas necessidades do mercado, nomeadamente no que respeita ao acesso atempado do público e profissionais de saúde. Avalia também os desafios que os ON enfrentam, como lacunas nas orientações, atrasos operacionais e restrições de recursos, que têm profundas implicações para os fabricantes. A investigação combina a análise quantitativa das bases de dados disponíveis ao público com as percepções qualitativas das entidades envolvidas. Foi dada especial atenção às disparidades entre os ON em termos de designação, eficiência e cumprimento do RDM. As conclusões destacam disparidades significativas na disponibilidade e no âmbito dos ON. O estudo foca a necessidade de resolver os desequilíbrios regulamentares e aumentar a transparência. Também explora os potenciais riscos de monopolização do mercado por parte dos grandes ON, salientando a importância de práticas equitativas para manter a concorrência e promover a inovação. Esta investigação apresenta sugestões para melhorar processos e alinhamento regulamentar dos ON, com vista a salvaguardar a saúde pública e apoiar o avanço tecnológico e a diversidade do mercado. O estudo salienta a importância da supervisão e da colaboração entre entidades reguladoras, ON, fabricantes e outras entidades para resolver as actuais ineficiências e apela ao reforço e à publicação atempada das orientações para simplificar os processos de certificação. Eliminar lacunas em recursos, transparência e eficiência ajudará a Europa a cumprir o seu compromisso de promover a segurança, a acessibilidade e a inovação nos cuidados de saúde.
The regulation of medical devices is critical to ensure safety and quality in healthcare. The European Union’s Medical Device Regulation (MDR) has introduced a robust framework to address these goals, placing significant responsibility on Notified Bodies (NBs) as independent entities tasked with assessing conformity and enabling market access. This thesis investigates the growing role of NBs within the medical device industry and their influence on market accessibility, safety standards, and possible impact on innovation. Key objectives include examining NBs' capacity to meet MDR demands and effectively manage the certification process. The study identifies gaps between NBs' designation and the diverse needs of the medical device market, particularly regarding timely access to the public and healthcare professionals. It also evaluates the challenges NBs face, such as guidance gaps, operational delays, and resource constraints, which have profound implications for manufacturers. The research combines quantitative analysis of publicly available databases with qualitative insights from stakeholders. Special attention was given to the disparities between NBs in terms of scope, efficiency, and compliance with MDR requirements. The findings highlight significant disparities in the availability and scope of NBs. The study focuses on the need to address regulatory imbalances and enhance transparency. It also explores the potential risks of market monopolization by larger NBs, emphasizing the importance of equitable practices to preserve competition and foster innovation. This research provides actionable insights into improving NB operations and regulatory alignment to safeguard public health while supporting technological advancement and market diversity. It also stresses the importance of robust oversight and collaboration among regulators, NBs, manufacturers and other stakeholders to address current inefficiencies. It calls for enhanced guidance and timely publication of supporting documents to streamline certification processes. Closing resources, transparency, and efficiency gaps will help Europe fulfil its commitment to advancing safety, accessibility, and innovation in healthcare.
The regulation of medical devices is critical to ensure safety and quality in healthcare. The European Union’s Medical Device Regulation (MDR) has introduced a robust framework to address these goals, placing significant responsibility on Notified Bodies (NBs) as independent entities tasked with assessing conformity and enabling market access. This thesis investigates the growing role of NBs within the medical device industry and their influence on market accessibility, safety standards, and possible impact on innovation. Key objectives include examining NBs' capacity to meet MDR demands and effectively manage the certification process. The study identifies gaps between NBs' designation and the diverse needs of the medical device market, particularly regarding timely access to the public and healthcare professionals. It also evaluates the challenges NBs face, such as guidance gaps, operational delays, and resource constraints, which have profound implications for manufacturers. The research combines quantitative analysis of publicly available databases with qualitative insights from stakeholders. Special attention was given to the disparities between NBs in terms of scope, efficiency, and compliance with MDR requirements. The findings highlight significant disparities in the availability and scope of NBs. The study focuses on the need to address regulatory imbalances and enhance transparency. It also explores the potential risks of market monopolization by larger NBs, emphasizing the importance of equitable practices to preserve competition and foster innovation. This research provides actionable insights into improving NB operations and regulatory alignment to safeguard public health while supporting technological advancement and market diversity. It also stresses the importance of robust oversight and collaboration among regulators, NBs, manufacturers and other stakeholders to address current inefficiencies. It calls for enhanced guidance and timely publication of supporting documents to streamline certification processes. Closing resources, transparency, and efficiency gaps will help Europe fulfil its commitment to advancing safety, accessibility, and innovation in healthcare.
Descrição
Tese de mestrado, Regulação e Avaliação do Medicamento e Produtos de Saúde, 2025, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
204100453 Medical device regulation Notified bodies European Union Gap analysis Teses de mestrado - 2025