5 Ways to Conduct Post Market Surveillance

There is wide-spread confusion among medical device manufacturers as to the enforceability of some of the EU MDR and IVDR requirements. This is understandable given the frequent postponement of overall deadlines for introduction but needs to be corrected immediately to ensure products can continue to be sold on the EU market and, above all, to safeguard patient safety.
 
Specifically, among the new or enhanced requirements under MDR Post Market Surveillance (PMS), Periodic Safety Update Reports (PSUR), Post-Market Clinical Follow up (PMCF) and the need for an appointed Person Responsible for Regulatory Compliance (PRRC)—unless only selling legacy devices—have already been an applicable requirement since May 26, 2021 for all medical devices sold into the EU, regardless of a device’s MDR CE Marking status.
 
The renewed focus on customer safety in the MDR drives the underlying principle that it is no longer sufficient to only address issues further to a complaint, but manufacturers must gather clinical and safety-related data after completion of the CE certification process, approval and market access. PMS is one such non-negotiable activity that can yield additional business benefits, such as informing product development and revealing new market opportunities. Despite this, PMS is a cyclical process that requires expertise and numerous man hours so the burden placed on in-house teams must not be overlooked.
 
To assess the efforts required to complete PMS effectively and establish suitable procedures to ensure it is carried out effectively, it is useful to classify key activities into five areas. These channels and sources need to be cyclically monitored by specialist teams:

1. Published Literature

Published literature pertaining to the product, similar products or to the pathologies the device is relevant to cannot be missing from the PMS review process.
 
These sources provide authoritative clinical evidence and research that may highlight potential risks or conversely provide stronger proof of a product’s clinical benefit. Either way it would be strongly against the manufacturer’s commercial interests to overlook these key publications.

2. Device Users and Patients (Where Relevant)

Medical device manufacturers need to establish an ongoing two-way conversation with users of medical devices and their patients where this is relevant to uncover safety issues that may emerge in every-day use.
 
Engaging with this audience is also key to identifying potential off-label uses. Manufacturers need to be fully aware of any off-label use and ensure that steps are taken rectify the issue.

3. Combing Through Social Media Channels

In an ever more connected world, social media is often the first port of call for users and patients to share their real life experiences with a device. Monitoring these channels ensure that potential issues with the manufacturer’s device, similar devices or off-label use are identified rapidly and effectively.
 
Social media monitoring is also useful to ensure that marketing and communications departments are aligned with company compliance and messaging, such as not endorsing off-label use of devices.

4. Monitoring Competitor Device Performance

Checking competitor performance provides new data for ongoing clinical evaluation and can help demonstrate compliance with the new regulations. It is good commercial practice but also supports the ongoing assessment of ‘clinical benefit’ and ‘state of the art’ (SOTA), which play an important role in the new regulations.

5. Risk Data Reassessments

Unfortunately, while manufacturers tend to prepare risk management documents for the launch of their products, too many become lax with updating them with new statistics and data over time. This activity should, however, be carried out regularly, at least every year, according to best practice examples.
 
PMS is a requirement that medical device and orthopedic device manufacturers would do well to address immediately as it is a key step towards building MDR compliance. Failure to get PMS processes adequately set up results in incomplete, inaccurate data that puts the company’s competitive potential at risk and could endanger patients.  Manufacturers that maintain devices on the market under the transitional provisions are in fact unable to make any significant changes in design or intended purpose of that device (MDR Article 120(3)), severely limiting their competitive advantage.
 
The requirements outlined are conditional to maintaining the device on the market under transitional provisions (MDR Article 120) and existing certificates may only remain valid provided that the required surveillance is also completed by the NB that issued the certificate. With the new focus on pre-emptive action in the new regulation, having cyclical processes under control becomes essential to helping staff avoid becoming overburdened as they race to meet deadlines.