What does post-market surveillance and vigilance mean for you as a manufacturer?
Post-market surveillance is the tracking of the medical device on the market throughout its life cycle. To prove the safety and performance of the medical device, the analysis and evaluation of customer complaints is no longer sufficient.
The legislator stipulates that a proactive examination of one’s own medical devices and those of competitors must be demonstrably carried out and appropriate measures initiated if the medical device no longer meets the state of the art in terms of safety and performance as well as the risk-benefit ratio. The PMS plan shows how this is to be done on a product-specific basis and which methods are to be used to achieve the declared goal of tracking.
How do you effectively use the PMS process for your business?
A structured approach is necessary to:
- Plan time and effort
- Plan resources
- Plan financial effort
- Define the clinical objective
- Understand potential risks of the planned interventions
It is important that both the passive collection of market data via customer complaints and the proactive measures of data analysis and data collection are coordinated to create as holistic a picture as possible of the safety and performance as well as residual risks and clinical utility of the medical device.
Already during the development of a medical device, you as a manufacturer should think about the planning of PMS activities, because often the costs and efforts of the medical device are underestimated after the initial marketing.
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 market tracking should be done and communicated requirements that both the methodology of tracking and the evaluation of results are done in accordance with the rules.
Every medical device must be included in the process of product tracking in the market. The effort required to do this depends on the risk of the product, as well as the preclinical and clinical data situation and the outcome of the risk assessment. These aspects must be included in the planning of post-market surveillance activities. Only when the methodology is documented on a risk basis can it be ensured that the effort for PMS activities is targeted and can be carried out efficiently.
What happens once the product is on the market?
Is that the end of the line?
Every medical product must be tracked over its entire life cycle in the market. This includes not only the evaluation of customer complaints, but increasingly also the proactive interaction with the customer, through literature research and evaluation of databases to be able to prove that the medical device can be used safely and effectively according to its intended purpose.
We help you to perform PMS in an MDR-compliant and efficient manner. Please contact us.
What is the difference to Post-Marketing Clinical Follow-Up?
The legislator stipulates 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 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 fulfills its responsibility to track its own medical devices after they have been placed on the market. Both passive complaint handling activities, which include the so-called vigilance system, and proactive follow-up through the manufacturer’s own research, clinical data and demonstrably continuous data collection play a major role. The basis for these activities is risk management, which as an integral approach records and evaluates the risks of the product and helps to determine suitable measures to assess the product as safe and efficient over the entire life cycle.
What are the main challenges with the PMS and vigilance for medical devices?
The main challenge is to develop a good study protocol addressing 3 critical points
We shape the list of clinical claims and figure out the actual clinical claims and increase the success rate your device.
The next step is to define proper parameter that will be tested in clinical trials. Should you choose the wrong claims and parameter for testing, the whole clinical trial is useless.
We make sure that your product is compliant with the existing standards and regulations.
Imagine hiring external support to tell you what needs to be done in the PMS process to keep your product in the market. You are then either busy guiding and managing other teams to help you with the PMS, or you and your team are completely consumed with executing the PMS plan yourself. In both cases, you are left with the work (and actually, you don’t have time for it).
We develop the PMS plan for your and implement every step of that plan. Instead of spending way too much time on project and team management, you can focus on the essentials of your business while we watch your back and take care of the PMS.
How do we conduct a 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 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 have secured their successful future in medical technology through our collaboration:
Project management for development of a class IIb/ III product
The company: Internationally active medical technology company in the field of orthopedic implants and instruments.
The task: Review and set-up of processes for CE marking and product registration of medical devices.
Our activity: We evaluated the status quo of processes for CE marking and product registration of Class I, IIa, and IIb medical devices and implemented additional processes to ensure that regulatory requirements for conformity assessment of both national and international registrations are met. This involved optimizing Regulatory Affairs’ interfaces with other departments and taking steps to integrate the new processes and structures into the company’s quality management system.
Customer benefits: Targeted measures created structures and processes that enabled our customer to optimize its internal processes for CE marking and improve communication with Notified Bodies and national registration authorities. The sustainability of our measures was confirmed in audits.
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.
“When words were followed by actions and actions by results, I was more than convinced! Thanks to 3R LifeScience, we were able to successfully complete more than a singular product development and bring a product to market that has a great impact for our patients.
In addition, we were able to do a great deal of groundwork of an organizational nature within the company, from which we will benefit in the long term.”
Berlin Heart GmbH