Medical Device Registry

A Medical Device Registry is a specialised form of clinical investigation that generates high quality Real World Evidence (RWE) on the safety and performance of medical devices.

A well-designed registry will be capable of meeting the full range of requirements for Post-Market Clinical Follow-up (PMCF) as specified in MDR Annex XIV Part B, helping to future-proof regulatory approval for the subject device.

Under the MDR, PMCF systems must be able to collect and use clinical evidence in order to:

  • update the Clinical Evaluation,
  • ensure continuing acceptability of benefit-risk profile,
  • detect any emerging risks and previously unknown side-effects,
  • confirm safety and performance of the medical device,
  • identify any systematic misuse of the device.

Meeting all these requirements requires a powerful PMCF system with enough scope and flexibility to capture a wide range of outcomes from within a single, standardised framework. The PMCF system must also provide data on the medical device throughout its entire lifetime, meaning that the PMCF system must not be inherently limited by time or recruitment number.

In the absence of a nationalised registry, a medical device registry represents the gold standard in generating the evidence required for PMCF of medical devices.

Features that make a registry particularly suited to producing data for PMCF under the MDR include:

  • producing data that represents the entire population normally exposed to the device,
  • focusing solely on the performance of the subject device rather than making external comparisons,
  • an ability to confirm or refute the meeting of safety and performance objectives when the device is used as intended “out there in the world”
  • lack of an upper limit on recruitment number or study run time, enabling the collection of data throughout the entire lifetime of the device from a single system,
  • inherent applicability to all types of clinical site, meaning that data collected truly represents outcomes obtained through normal use of the device.

Investing in the construction of a Medical Device Registry is highly recommended and will enable ongoing provision of the PMCF data necessary for continuing regulatory approval under the MDR.

Developing a Medical Device Registry is a speciality of Mantra Systems. It is task that requires a detailed understanding of clinical investigation design, laws and regulations, ethics, technical documentation, and investigator engagement.

Our specialist registry advisors offer:

  1. Clinical investigation design expertise, helping to ensure that the registry collects data in a standardised way from all clinical sites, minimising bias and data quality variability. A registry requires a detailed, documented method developed according to principles in MDR Annex XV, Good Medical Practice, and relevant MEDDEV guidelines.
  2. Knowledge of laws and regulations, ensuring that the registry is constructed in accordance with rules relating to patient consent, data protection and healthcare compliance. In Europe, the GDPR requires that particular attention is paid to how patient data is collected, handled and stored.
  3. An understanding of ethics requirements, ensuring that the registry is undertaken in compliance with the full range of approval required in each geographic territory. Rules on ethics approval vary between countries and navigating requirements draws upon relevant experience.
  4. Experience writing technical documentation such as a Clinical Investigation Plan (CIP), investigator’s brochure, informed consent forms and data processing agreements that must be produced for each registry. Drafting these documents requires clinical expertise and a deep knowledge of study design.
  5. An ability to drive investigator engagement through direct clinical experience and extensive knowledge of clinical investigation methodology. Engaged clinical investigators means a higher level of data entry compliance, motivation, and patient follow-up. In turn, this leads to a more complete and valuable data set.

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