Post-market. Continued compliance

Your device is on the market, but this does not mean your regulatory journey is over. The Medical Device Regulation (MDR) is built around the idea of risk throughout the lifetime of the device, therefore continued monitoring and collection of clinical data is mandatory. However, what kind of data a manufacturer needs to collect and what are the most efficient ways to gather clinical data in the post-market phase depends on your device’s risk classification, intended use, indications and intended patient population, to name just a few of the main factors to consider for post-market activities.

As all documents and pieces of information about your device are or should be connected, the clinical evaluation process and its outcomes will have highlighted what gaps may exist in your clinical data. Perhaps one of the populations for which your device is indicated is underrepresented in your clinical studies. Maybe you based your initial CE marking on equivalence and now you need to collect data on your device. Perhaps there are unanswered questions around safety of your device in some specific section of your population. In addition to general PMCF activities, expected for all medical devices under MDR, specific PMCF activities, tailor-made to suit your device’s clinical data needs, should be planed and reported on as part of your continued compliance to regulatory requirements.

Results of specific PMCF activities, together with periodic updates of systematic literature reviews and vigilance database searches, as well as data from general PMCF activities such as complaints monitoring and user feedback all feed into periodic updates of your clinical evaluation.

What Ariadna Regulatory can do for you in the post-market phase

  • Plans and Reports for specific PMCF activities that are tailored to your clinical evidence needs and aligned with device risk profile and Notified Body expectations
  • Periodic updates of systematic literature reviews and vigilance data as part of your continued compliance and post-market surveillance activities
  • Periodic updates of the Clinical Evaluation because a clinical evaluation is not a collection of documents, it is a process that continues to integrate new information throughout the lifetime of your device