Safety & Performance Clinical Data

Clinical Experience data, published in peer reviewed journals, can provide a quick, compliant, and economical solution for your Clinical Data.

Clinical Data is a regulatory necessity for maintaining your medical device in the market. It requires a rigorous, proactive, and coherent approach in collecting evidence of its safety and performance. However, that can be a lengthy and expensive process.

At Evnia, we’re committed to accelerating innovation within the medical device industry – while maintaining a sterling regimen of safety and regulatory compliance – and are invested in supporting manufacturers to deliver quality medical devices to the market faster.

Evnia’s new approach to collecting your Clinical Data without the need for clinical investigation

In order to help manufacturers, comply with the Medical Device Regulation requirements on clinical data, we leverage actual Clinical Experience activities and data creation. This feeds into peer review publications to support Post-market Clinical Follow-up (PMCF) and, ultimately, your Clinical Evaluation Report (CER) activities. 

In contrast to Clinical Investigation activities that are both recourse and time-intensive, Clinical Experience activities can provide reliable data in an economical and time-efficient manner. 

Our in-depth experience with the Clinical Evaluation process, over the years, has revealed a systemic gap for manufacturers today:

  • Not having adequate clinical data to support the clinical evaluation process, even for devices that have been in the market for decades.
  • Not having an ample strategy for peer reviewed publications that are providing evidence and insight into the device safety and performance characteristics.  

With our dedicated service, we help medical device manufacturers to accelerate the collection of unbiased, independent assessment data through clinical experience activities, feeding into peer review publications in support of your performance and safety data. 

Moreover, the same peer review publications can act as additional marketing and promotional materials, geared towards key industry stakeholders, like doctors and surgeons.

Envia' s process for clinical experience data collection

Manufacturers have several options to create valid Clinical Data, in support of their device performance and safety claims.

According to Reg. EU 2017/745 and EU 2020/561 art. 2 (48) of the Medical Device Regulation (MDR), Clinical Data is defined as information concerning the safety and performance, generated from the use of the device and sourced from the following:

  • Clinical Investigations of the device concerned.
  • Clinical Investigations or other studies reported in scientific literature of a device, for which conformity to the device in question can be demonstrated.
  • Reports, published in peer-reviewed scientific literature on other clinical experience of either:
    1. Device in question
    2. Device for which conformity to the target device can be demonstrated.
  • Relevant clinical information, coming from post-market surveillance and specifically the Post-market Clinical Follow-up.

What Evnia does is support manufacturers by providing a solution to collect clinical experience data through it's own European Clinical Network:

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  • Engaging with physicians and hospitals that can support data generation.
  • Data-gathering and analysis.
  • Creating a publication strategy to generate peer reviewed articles that address the performance and safety of a device.
  • Using this data to write and publish peer review publications that address the established parameters for the performance and safety of the device;
  • Provide Clinical Experience data to the Clinical Evaluation Report.

Contact us today by going to our contact page or call us at +45 88 82 57 97 to evaluate your needs towards achieving regulatory compliance.

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