Post-Market Radar: FDA and MDR/IVDR compliant post-market surveillance

1. PMS: What is required from you by law

The FDA regulates in 21 CFR part 822 exactly:

• when post-market surveillance is necessary,
• what manufacturers must consider when planning post-market surveillance,
• what documents manufacturers must provide, and
• How quickly manufacturers must respond or FDA will act in the event of a problem.

On May 16, 2016, the FDA published a guidance document specifically on 21 CFR part 822 to provide further assistance to manufacturers. (updated draft from May 2021)

The EU’s Medical Device Regulation (MDR) lays down exhaustive requirements for Post-Market Surveillance (PMS):

• Chapter II Article 10: The QM system adopted by every(!) Manufacturer must include a post-market surveillance system (PMS).
• Chapter II Article 15: The “person responsible for regulatory compliance” must monitor this PMS system.
• Chapter VI Article 61: Manufacturers must include post-market surveillance data in a clinical evaluation.
• Chapter VII Article 83: Manufacturers are obliged to plan, establish, document, implement and maintain a PMS system.
• Chapter VII Article 84: The manufacturer also must set up a post-market surveillance plan (PMS plan) for each product.
• Chapter VII Articles 85 and 86: The MDR requires manufacturers to prepare regular reports on the results of post-market surveillance.
• Annex III describes in detail which elements should be included in the plan.

ISO 13485:2016 also requires a system that continuously collects and evaluates information and helps users determine what measures are needed.

Conclusion: The laws require manufacturers to plan and operate effective post-market surveillance systems. These systems must systematically and continuously collect and evaluate all relevant information. 

PLEASE NOTE: A violation of these requirements may result in a major non-conformance in the audit and, in the worst case, a suspension of the certificate.

2. The challenge of the PMS process

It is no surprise that many manufacturers feel overwhelmed by these legal requirements:

1. Quantity of information sources
   The number of sources of information is constantly increasing. While many auditors used to be satisfied with merely analyzing the BfArM reports, manufacturers today are expected to collect and analyze all available data:
   this includes additional government databases such as SwissMedic, FDA and, in the future, EUDAMED, social media channels such as Twitter or LinkedIn, SOUP manufacturers´ and other suppliers´ websites, databases outlining IT vulnerabilities such as those in NIST, etc.
2. Unmanageable amount of information per source
   The sheer number of publications is becoming a challenge. The NIST is required to publish thousands of reports. Every month! The number of notifications to the authorities is growing every year. Social media also provide an unmanageable amount of information. This is like searching for a needle in a haystack.
3. Lack of accessibility and analyzability of information
   Most of the information is publicly available. However, it is difficult to access and analyze: Each source uses a different format and interface, and these are constantly changing. The data sources are difficult to search. For example, searches on the BfArM page do not include manufacturer reports. Searches by search terms are sometimes ineffective because product codes need to be entered. It is highly likely that a great deal of information can be simply overlooked.
4. Frequency of publications
   Collecting and evaluating post-market data once a year? This was perhaps acceptable in the past. Today, for example, the UL 2900-2-1 standard recognized by the FDA expects published IT vulnerabilities to be addressed within two weeks.
5. Monitoring effort
   The consequence of the aforementioned points is clear: the effort required to continuously collect post-market data is reaching a level that exceeds the capabilities of many companies, in terms of resources, time, and money. 

Conclusion: The amount of available post-market data is growing exponentially. As a result, it is increasingly difficult to find all relevant information in a timely manner with reasonable effort.

3. How the Post-Market Radar helps you

a) How it works

The Post-Market Radar automates the following steps in whole or in part to continuously (!) collect and evaluate information:

• Download or/and retrieve data from a wide range of information sources that you choose
• Transfer data to standardized and searchable formats
• Search data based on search terms that you specify
• Filter out redundant and non-relevant information (minimize false positives)
• Submit the results to the experts of the Johner Institute for a final assessment and to add recommendations for action
• Generate and send manufacturer-specific or product-specific reports

b) Reports

You decide how often you want to receive the reports. The report displays an overview in table form:

• Source where the information was found
• Search terms or other criteria that led to this source
• The information itself, e.g. the passage in the text
• Link to the source of information, e.g., to a scientific publication on PubMed or to a manufacturer’s report published by the BfArM 
• If necessary, recommendations for action

4. How you benefit from Post-Market Radar

Post-Market Radar not only reduces your workload. This service also supports you by improving compliance efforts while saving costs. This is made possible for the following reasons:

• Cost reduction by leverage
  You benefit from the fact that the Johner Institute conducts research for a large number of companies, which practically share the costs of (additional) design and development, and operation of the system. The Johner Institute transfers this cost saving to you.
   
• Cost reduction by automation
  The Johner Institute has developed bots that search across all sources on a daily basis. This automation saves on manual effort, which translates into lower costs.
   
• Increased probability of finding all relevant reports
  Reliable bots query more data sources than you could ever do manually. Our algorithms for minimizing false positives limit the reports to the results that are actually relevant to you.
   
• Improved compliance and audit reliability
  Auditors receive training on the topic of post-market surveillance. A transparent process that identifies all relevant information will avoid unnecessary findings in the audit. Since many auditors conduct quick research of the manufacturer’s products before the audits, it would be embarrassing if you did not find this information beforehand. Post-Market Radar helps to avoid exactly these kinds of situations.
   
• Safer products and lower risks
  Compliance is one thing. The other is the spirit of post-market surveillance: protecting patients from any risks resulting from non-compliant products as effectively and quickly as possible. Nothing would be more fatal for patients and the manufacturer than safety concerns which went undetected due to an inadequate monitoring.

5. How to find out more

Let's find out how we can help you monitor the safety of your products with Post-Market Radar.