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.
How do you effectively use the PMS process for your business?
A structured plan is necessary to:
- Collect and analyse complaint data
- Proactively plan additional surveillance activities to
monitor products under real clinical conditions
- Implement gathered data into the risk management
- Report any serious risks about the marketed products
- Implement measures to address product deficiencies
- Realign surveillance activities according risk
- Plan for PMCF studies if clinical data is not sufficient
to address clinical product risks.
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 via the risk management process of the legal manufacturer to create as comprehensive risk profile of the marketed medical devices. Necessary actions including field safety corrective actions as well as CAPA measures need to be concluded from these activities.
The Quality Management System reflecting an integrated risk management approach is important to efficiently plan for all PMS activities. As a legal manufacturer, you should start planning during development even if a pre-market clinical study is needed. The legislator increasingly wants to understand how a medical device performs under real market conditions. Without a plan this remains expensive, time consuming and risky.
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.
Every medical product must be monitored over its entire product life. This includes not only the evaluation of customer complaints, but also the proactive interaction with customers and users, scientific literature research and regular evaluation of databases to prove that the medical device can be used safely and effectively according to its intended purpose.
What happens once the product is on the market?
Is that the of your responsibilitie?
No. Your responsibilities as a legal manufacturer cover the entire lifetime of you product. New challenges may arise from its use under normal market conditions. This needs to be reflected in your risk management processes.
We help you to perform PMS activities in an MDR-compliant and efficient manner.
Please contact us.
and performance based on its own data.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.
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.
We develop the PMS plan for your product portfolio 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 take care of the PMS.
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:
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