The EU MDR and IVDR will usher in increased post market surveillance (PMS) requirements for all MedTech companies, mandating a PMS plan that includes a Post-Market Clinical Follow-up (PMCF) plan or justification for why it is not required. Higher-risk devices and IVDs will require a Periodic Safety Update Report (PSUR), while for lower-class devices, a Post-Market Surveillance Report (PMSR) will be required. This future landscape requires MedTech companies to maximize their PMS by using real world data to detect signals of defective devices in the field before a recall becomes necessary.
While some MedTech companies are optimizing their PMS approach by creating their own evidence platforms, others are still working out their strategy. The unfortunate ground reality is that most companies over commit on their PMS plan to carry out PMCF, vigilance, event monitoring, PSURs, but they don’t follow through on their CER promises due to a lack of time, resources and funds.
Put simply, the key challenges with PMS are as follow:
- How to identify the data that can aid their PMS efforts
- How to generate new data in a timely manner to support PMS
- How to dedicate time and resources for PMS documentation
MDR Vigilance – An Added Challenge
The new vigilance reporting timelines under the MDR and IVDR require manufacturers to report incidents within 15 days, rather than 30 days, which will worsen the aforementioned challenges. Companies now have only 24-72 hours to address critical incidents eg deaths from devices. Without an automated system, it is extremely difficult to monitor these events consistently.
While most MedTech companies are sitting on an incredible amount of real-world data that they collect through their devices, or through registries they’ve implemented, this data is rarely put to good use!
Within a large number of MedTech companies today PMS is decentralized, with siloed departments managing product safety and patient vigilance data, including Quality Assurance or Regulatory Affairs. Although some really valuable and useful information is available with departments outside QA/RA systems, information from user meetings, brand surveys, and social media often is not adequately captured, assessed, and trended.
- A thorough examination of all types of activity carried out around the organization will in turn help identify the types and value of data gathered from those activities with regards to PMS.
- An ideal PMS system would take in both reactive data (vigilance reports, audits, complaints, out-of-specification reports) and combine it with proactive data (service reports, literature, social media, real world evidence, and customer surveys ) such that all of the available data can be evaluated as one set.
- A set of processes, such as prioritization algorithms, to handle the incoming data and events in a timely and efficient way will help decide on necessary actions.
Implementing a centralized approach and system that pulls PMS data from all available sources for reporting and signal detection will enable Med-tech companies to stay ahead of safety trends and signals; thus, ensuring that their devices in the field are highly safe and effective for their customers.