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In case where the national registry is not available, which represent the gold standard source of RWE for medical devices. The design of the registry by sponsor is possible and it can be carefully controlled to ensure that sources of bias are eliminated.

REGISTRY UNDER MDR, A well-designed registry capture high RWE data on device performance, adverse events, emerging risks, trends of side-effects, and systematic misuse, meeting the full range of requirements for PMCF as specified in MDR Annex XIV Part B and ensuring regulatory acceptability of PMCF methods both now and into the future.  

Hierarchies of clinical evidence under MDR :

One question that arises, what is the level of evidence of patient registries within the hierarchies of evidence that are frequently used in developing guidelines or decision-making. As observational studies, registries would be placed in a subordinate position to RCTs.

Registry under mdr Challenges :

Data quality: 

Ensuring the quality of data must be one of top priorities of the sponsor. This task requires resources, expertise and coordination between the clinical investigator and the CRO for registry under mdr 

Recruitment and retention  

Recruitment and retention of patients are important in the design and excution of a registry. The main challenge described is the difficulties with patient enrollment, losses to follow-up, and certain sites contributing the majority of patients, can have profound negative consequences on the study validity because the patients that are enrolled are not randomized.

Sample size:  

A small registry with few patients and data points may be easier to execute, but the data could lack depth and be less meaningful. 

If the sample size of a key unit of analysis is not sufficient to detect a clinically important difference, the validity of the entire study is weakened. 


Our team is led by former notified body and competant authority leadership. They have significantly contributed to MDCG guidance documents on clinical evaluation, sufficient clinical evidence, and PMCF. They were also involved in the development of the requirements of MEDDEV 2.7/1 rev 4, which are now reflected in the MDR. 


At the end of a clinical trial, there is usually limited knowledge of the medium and long-term safety and performance of the device. The medium- and longer-term safety and performance of a device is estimated on the basis of premarket trial durations, that are generally inadequate to validate extrapolation hypothesis in real life, particularly implant longevity hypotheses. 

The aims of collecting RWE data as part of PMCF activities are: 

  • Study population that represents the entire population indicated in the IFU.  
  • Does not involve experimental exposure.  
  • Aiming to cover the “entire lifetime of the device 
  • Is conducted at all types of clinical site, not just specialist units  

ECLEVAR can help in collecting the clinical data required and provide long-term clinical strategy that support your business in EU, UK and Australia.

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Comme le montre le rapport d’évaluation clinique, les allégations prévues sur la sécurité et les performances cliniques ne sont pas suffisamment étayées par des preuves cliniques existantes. Afin de maintenir le “dispositif vasculaire” sur le marché européen, le client doit mener une étude PMCF pour générer des données cliniques suffisantes conformément au “Chapitre VI – Évaluation clinique et investigations cliniques, spécifiquement les sections 62 – 82”. Ainsi que la norme ISO 14155:2020


Confirmer la sécurité et les performances du dispositif vasculaire pendant toute sa durée de vie prévue et dans les deux emplacements anatomiques : Carotide et fémorale.
Identifier et analyser les risques émergents sur la base de preuves factuelles,
Assurer l’acceptabilité continue du rapport bénéfice-risque mentionné dans le rapport MDR de l’UE.
Identifier une éventuelle mauvaise utilisation systématique ou une utilisation hors indication du dispositif X, en vue de vérifier que l’objectif prévu est correct


Un sponsor a mené une étude multicentrique RWE pour collecter des données cliniques sur les dispositifs vasculaires. L’objectif était d’examiner les résultats à court et à long terme de l’utilisation du dispositif lorsqu’il est exposé à une population plus importante et plus variée.

Toutes les données ont été extraites des dossiers médicaux de chaque patient à partir du moment de l’intervention chirurgicale (considérée comme la ligne de base de l’étude) jusqu’à un maximum de 3 ans après l’intervention.

300 sujets ont été évalués sur 3 sites différents. 150 sujets ont été évalués dans la région carotidienne et au moins 150 dans la région fémorale.


Contribue à l’élaboration d’un plus grand ensemble de preuves :
Population représentative
Accepté par l’organisme notifié pour le certificat MDR.
Limitation : Preuves à long terme incomplètes.

Solution : Mise en place d’un registre vasculaire européen

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Vascular protheses Registries of 500 patients suffered from incomplete documentation and losses to follow-up. By linking data to a single-payer national claims database, the sponsor registry may be enriched and the quality enhanced.  

The objective of the proxy SNDS is linkage of vascular protheses registry populations to national reimbursement data 


Improved data completeness and minimized loss to follow-up. 92% of patients in the SNDS could be linked. Rates of losses to follow-up over 5 years were 1.0% in the linked population compared with 39% based on electronic case report form documentation. Mortality curves for populations based on SNDS and electronic case report form data were practically superimposable. 


Linking data from the SNDS database to the sponsor registry can close data gaps and practically diminish drastically losses to follow-up in the registry population.


The main objective of any clinical evaluation is to demonstrate the safety and performance of a medical device. This is an essential process that is part of the conformity assessment procedure for obtaining the CE mark.

In the MDR, the scope and emphasis of the clinical evaluation is more important than in the MDD.

Eclevar, a CRO specialized in medical devices, hosts a 45-minute webinar dedicated to the changes in clinical evaluation under the MDR. In this webinar, we will review the requirements for clinical evaluation and the best practices to address these changes effectively.