Article type
Abstract
Background Since the introduction of a new Medical Device Regulation (MDR [2017/745]) to impose higher requirements for medical devices, in European Union, notified bodies have the authority to issue certificates of conformity that are subject to specific conditions that mandate the collection of further clinical data within a specified period after the high-risk medical device's initial market entry. We examined how these schemes are operated worldwide within the paradigm proposed by Sustainable Development Goal 3.d.
Objectives We examined how these schemes are operated worldwide within the paradigm proposed by Sustainable Development Goal 3.d.
Methods A search strategy was performed by an Information specialist. The screening phase was carried out by 2 members of the group, in case of discrepancies a third researcher solved conflicts. Covidence was used as screening tool for study selection. Among selection criteria, Class III and implantable medical devices (high-risk medical devices) were our main population, and phases like premarket were excluded. We aimed to understand the concept of „conditional approval“in various regulatory jurisdictions. Results were synthesized and presented in summary formats such as tables, figures, and/or flowcharts, highlighting its essential features. The involvement of the public and/or consumers was not part of this project.
Results Our bibliographic database searches yielded 2069 studies, with seven studies meeting inclusion criteria for qualitative analysis. Data retrieved included authors, population, databases, objectives, countries, observations and Amstar-2's Quality Score, regulatory structure, key elements of post-marketing surveillance and vigilance activities, medical device registry, etc. were some of the data retrieved from our research.
Conclusions There is a need for the EU to develop and implement systems for conditional approval (restrictions or limitations) outlined in the MDR for high- risk medical devices. This could ensure the availability of orphan devices and of innovative devices for unmet needs, while facilitating the generation of further evidence through post-market evidence generation. Standardizing medical device classification systems is essential to reduce the global variability in healthcare practices concerning the Sustainable Development Goal 3.d.
Objectives We examined how these schemes are operated worldwide within the paradigm proposed by Sustainable Development Goal 3.d.
Methods A search strategy was performed by an Information specialist. The screening phase was carried out by 2 members of the group, in case of discrepancies a third researcher solved conflicts. Covidence was used as screening tool for study selection. Among selection criteria, Class III and implantable medical devices (high-risk medical devices) were our main population, and phases like premarket were excluded. We aimed to understand the concept of „conditional approval“in various regulatory jurisdictions. Results were synthesized and presented in summary formats such as tables, figures, and/or flowcharts, highlighting its essential features. The involvement of the public and/or consumers was not part of this project.
Results Our bibliographic database searches yielded 2069 studies, with seven studies meeting inclusion criteria for qualitative analysis. Data retrieved included authors, population, databases, objectives, countries, observations and Amstar-2's Quality Score, regulatory structure, key elements of post-marketing surveillance and vigilance activities, medical device registry, etc. were some of the data retrieved from our research.
Conclusions There is a need for the EU to develop and implement systems for conditional approval (restrictions or limitations) outlined in the MDR for high- risk medical devices. This could ensure the availability of orphan devices and of innovative devices for unmet needs, while facilitating the generation of further evidence through post-market evidence generation. Standardizing medical device classification systems is essential to reduce the global variability in healthcare practices concerning the Sustainable Development Goal 3.d.