Work Package 3 explores methods to obtain and combine best clinical and scientific real-world evidence on clinical performance of high-risk medical devices in daily practice (post-marketing phase, for example from registries). It will also investigate how Notified Bodies are applying conditions to certificates of conformity.


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To review and develop methods for aggregating clinical data from real-world sources and registries across the lifecycle of high-risk medical devices

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To develop a web-based tool for the automated surveillance of reports relating to specific types of medical devices

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To advise how post-market clinical evidence should be generated, based on an analysis of notified bodies’ practices in applying conditions to certificates of conformity


This task aims to provide insights into how registry data can be leveraged to supplement evidence from Randomized Controlled Trials (RCTs) on performance and safety of high-risk medical devices in the post-marketing phase. To achieve this aim a decision framework was developed capturing both characteristics to judge the quality of registry data, endpoints used to determine performance and safety, and propose methodology and criteria to assess performance of these medical devices.

The first step in this task was to perform a systematic review to identify and review available EU cardiac and orthopedic medical device registries on several structural and methodological characteristics that determine the quality of registry data. It refers to the IMDRF definition of a registry that is focused to comprehensively cover the population at a reasonable scale, indicating that estimates should be generalizable to the population in a region or nation, which is also consistent with existing regulatory guidance on real-world data.

As a second step, the partners involved in this task aimed to validate the current Orthopedic Data Evaluation Panel (ODEP) ratings, as an example of currently available Objective Performance Criteria (OPC) which may inform methodology and criteria that will be proposed as part of the decision framework.

The goal of this task is to retrieve globally available curated regulatory information on alerts and recalls of high-risk medical devices from the official websites of European competent authorities and non-European regulatory authorities, in order to capture possible trends in reported
incidents that could be used not only for scientific analysis but also to provide information to Expert Panels for assessment of the need for CECP.

In this process, several challenges have been identified by studying the actual state-of-the-art in the field of application. First, the lack of harmonized global standard structured data for reporting notices of failure leads to the need of developing country-specific approaches. Moreover, not all countries have reported safety notices in English or have adopted the same EMDN taxonomy.

After a full analysis of the situation of EU and non-EU countries, a first validation of the proposed framework was performed using the Italian data (adopting the EMDN), thus obtaining very good results, also comparing two different entity resolution algorithms. As a second step, attention has been given to the following countries: Greece, Germany, the Czech Republic, Portugal, France, the Netherlands, and the United States.

Clinical evidence for new high-risk medical devices may be limited, so post-approval evidence plays a key role to support decision-making across the product life cycle. Worldwide, evidencedevelopment schemes may be specified by regulatory authorities. Some challenges associated with conditional access schemes for medical devices have been described, but not specifically for high-risk medical devices. The EU could recommend a system of conditional approval for medical devices. Such a system was not included in the MDR but instead Notified Bodies (NBs) have the authority to impose restrictions on certificates, which would achieve similar goals. Task 3.3 aims at assessing the clinical evidence after market access. While challenges for post-approval evidence development schemes for medical devices have been described outside the EU, special issues related to high-risk medical devices have not been reviewed.