What does post-market surveillance mean for you as a legal manufacturer?

Post-market surveillance covers all activities defined by the legal manufacturer to plan, gather and keep up to date clinical safety, performance and quality data throughout the lifetime of a medical device.  

Besides complaint handling processes, where product malfunctions, deficiencies and other issues are often provided by the customer, the legislator requires a proactive evaluation of marketed medical devices based on the manufacturers risk management process.  The objective is to demonstrate that under real market conditions the medical device represents the State-of-the-Art technology and market data substantiate safety and performance claims as laid out in the medical device regulation.

The PMS plan shows how this is to be done on a product-specific basis and which methods are to be used for post-market surveillance.

What are your obligations as a manufacturer?

With MDR 2017/745, the legislator has manifested that PMS activities are part of the manufacturer’s responsibility.

European legislation has clearly formulated how post-market surveillance should be done. The MDR communicated requirements but the interpretation and implementation into existing processes remains a challenge for many companies.

Every medical device must be included in the PMS process. The effort required to do this depends on multiple factors that should be assessed before activities are initiated. Only when the methodology is based on an integrated risk management approach considering available and comparable preclinical and clinical data, PMS activities are targeted and can be carried out efficiently.

What is the difference to Post-Marketing Clinical Follow-Up?

The legislator specifies that each medical device must be able to demonstrate safety and performance on the basis of its own data. With the introduction of MDR 2017/745, comparisons to other medical devices have been severely limited. A clinical follow up is necessary when clinical data on the marketed medical device is not available or severely limited, and further clinical data needs to be collected to improve the data.

In addition to literature searches, surveys, and other forms of clinical data collection, it may be necessary to generate further additional clinical data through formally set-up studies even after the device has been placed on the market. Formal studies may also be necessary to provide clinical evidence for an extension of intended use or following significant product changes.

To ensure that both the rational for follow-up and necessary studies are understandable and the effort is plannable and financially reasonable, the creation of a PMCF plan is so important. Depending on the data situation, it may be sufficient to conduct a survey or a clinical investigation may be necessary to methodically capture risks and benefits correctly.

Why should you as a manufacturer rely on external partners to conduct a PMS?

Today, the formal set-up of the methodology is still a hurdle for many manufacturers and it is unclear how much effort is required to set up PMS activities in compliance with the regulations. An independent third-party view of the product, risk management and existing data helps to set up appropriate and necessary processes and methods to meet regulatory requirements.

If additional clinical data need to be collected, professional planning is the key to a successful study. In most cases, the rules of a clinical study must be followed, and the study must be set up correctly in terms of methodology and objectives. The know-how is not always available at the manufacturers, especially if the products have been marketed in the past through equivalence comparisons.

How are PMS and quality and risk management related?

The manufacturer’s ISO 13485 quality management system must define how the manufacturer fulfils its responsibility to monitor its own medical devices after they have been placed on the market. Both passive complaint handling activities, which include the so-called vigilance system for reporting serious risks and market incidences, and proactive follow-up through the manufacturer’s own research, clinical data and continuous data collection play a major role. The basis for these activities is an integral risk management, which records and evaluates product risks and helps to determine measures for demonstrating safe and efficient use over the entire product life.

How do we conduct  post-market surveillance (PMS)?

Here is an infographic that illustrates our work and design process for a PMS. (Please note that this illustration is intended to provide a simplified view of the process. Individual steps are likely to vary from project to project). Click on the image to enlarge it.

Do not hesitate to ask us how a PMS could look like for your project. Simply use our contact form for this purpose.

These companies we have successfully supported:

Product portfolio recertification and MDR gap analysis

The company: Internationally active medical technology company with resorbable bone substitute materials.

The task: Planning and execution of the recertification of the product portfolio according to the European Directive as well as gap analysis regarding MDR requirements.

Our activity: We reviewed the technical documentation for the Class III product portfolio and created a new design dossier as part of the recertification. The new MDR requirements and requirements from technical standards were defined and implemented in consultation with the Notified Body.

The customer benefit: Our client’s product portfolio was recertified on time and within budget. New regulated requirements were reviewed and comprehensive remediation measures were initiated to further improve the documentation of the established product portfolio.