Medical Device Registry Under EU MDR

Medical Device Registry

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.

A well-designed registry captures 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.

Hierarchies of Clinical Evidence under MDR

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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 execution 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.

Clinical Registry Team

Our Clinical Registry Team

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Our team is led by former notified body and competent 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.

Our Services

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

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

Clinical Evaluation Pathway

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CER

Clinical Evaluation Report

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PMCF Plan

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PMCF Activities

Clinical Data Collection

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