Post-market surveillance has often been pushed aside by medical device manufacturers. However, regulatory bodies globally are starting to implement more rigorous requirements for post-market surveillance, so medical device manufacturers must start taking action to remain compliant. Regulatory bodies are shifting emphasis onto proactive approaches rather than relying on reactive systems, such as complaints monitoring. All of this is compounded by the imminent publication of the new medical device regulation (MDR).

Stricter regulations are being implemented to minimize impact on patient and user safety by making sure that any issue with a medical device is acknowledged as soon as possible. Manufacturers must understand and correctly implement the requirements for post-market surveillance in the geographies they are looking to distribute.

In order to help manufacturers meet new compliance regulations, the national competent authorities (NCAs) have been working toward ensuring that the requirements for post-market surveillance, as defined within the medical device directives, are more clearly defined and specified, leaving no room for misinterpretation and subsequently any surprises during the next regulatory body audit or review.

Post-market surveillance interpretations

Understanding and correctly implementing requirements has never been more critical for manufacturers wishing to introduce or maintain distribution of their devices within markets that have requirements for post-market surveillance, such as Europe and the United States. Unfortunately, there is a lot of room for misinterpretation within the new guidelines.

The MDD 93/42/EEC, Annex II, for example, stipulates manufacturers institute and keeps a systematic procedure up-to-date to review experience gained from devices post-production. This is to be treated as an addition to the provisions in Annex X, which require manufacturers to implement appropriate means to apply necessary corrective action and notify authorities.

Post-market surveillance requirements should be in direct relation to risks associated with the device based on its intended use, such as the product or technology being new to the manufacturer and the extent of the available scientific knowledge and market experience with similar products and technology. Providing incident reports to NCAs is mandatory when a serious deterioration in health is caused by a medical device. However, concluding what is a serious deterioration in health can be difficult.

For example, the Medicines & Healthcare Products Regulatory Agency (MHRA), the UK competent authority, considers the prolongation of surgery what requires additional anaesthetic to be administered as a serious injury, a benchmark of an extra 30 minutes being a trigger point. However, not all competent authorities are aligned, and it can be argued that no two surgeries are the same, and that a difference of 30 minutes cannot be considered significant.

As well as implementing stricter procedures and reporting, MEDDEV 2.12-1, Vigilance Guidance Document, Revision 5, was updated to include that all manufacturers have efficient systems for proactive scrutiny of trends in complaints and incidents. Manufacturers should provide trend reports to their NCAs whenever there is a significant increase in incidents that are normally excluded from individual reporting.

Post-market clinical follow up studies

MEDDEV 2.12-2, concerning post-market clinical studies, was created with the intention to provide guidance on when and how to conduct post-market clinical follow-up (PMCF) studies. This document emphasises the importance of post-market surveillance when trying to identify and investigate enduring risks associated with medical devices already on the market.

Factors influencing the need for PMCF can be:

  • Innovation
  • Significant changes to device or usage
  • Risk factors
  • Type of procedure
  • Population
  • Safety
  • Post-market surveillance findings
  • Emergence of new informationon safety or performance and CE marking

However, bear in mind that a PMCF might not always be required, usually because the medium- to long-term safety and clinical performance of devices is already established because data already exists from previous use of the device or where other post-market surveillance activities have provided enough data to prove that risks have been addressed. Manufacturers are still obliged to provide detailed justification as to why the PMCF was not performed.

Risks and benefits of post-market surveillance

Manufacturers who are not taking their post market surveillance seriously can receive large financial fines or face seizure of products, imposition of special compliance contracts, and jail terms for responsible executives.

Implementing an ongoing post-market surveillance investigation lets manufacturers quickly identify any needed improvements. Other benefits include lower complaint costs due to fewer incidents, and greater customer loyalty and engagement.

To meet compliance standards, manufacturers must implement processes to ensure they are compliant with the most up-to-date requirements for distributing in each region. This is extremely time-consuming; manufacturers who find themselves without the time or the resources to stay on top of international requirements should think about recruiting external help as needed.

Post-market surveillance should be viewed by manufacturers as the opportunity to ensure the early detection of device issues and protecting patient/user safety so that only devices proved to be as safe as possible remain on the market. In addition, early detection helps improve design and processes, which ultimately will drive manufacturers to produce better performing devices. This will not only increase the manufacturer’s overall sales, but it will boost the company’s reputation.

The challenge for manufacturers is to meet compliance standards in all countries in which they distribute devices and to provide evidence that they are keeping compliant. Manufacturers should make sure that they have proactive processes in place to identify current post-market surveillance requirements for all countries and ensure they keep up to date with changes. Some manufacturers will choose to implement procedures that detail requirements for each country, while others will adopt the highest requirements across the board for all countries. For manufacturers to solely rely on the notification of revision of applicable external documents leaves them open to periods of non-compliance and forces the business to implement very costly last-minute solutions to meet all compliance standards.

Maetrics

www.maetrics.com

About the author: Parminder Kalle is the senior solutions delivery manager at Maetrics and can be reached at +44.78.8740.6673 or pkalle@maetrics.com.