Post- market surveillance (PMS) is part of Europe’s medical devices regulatory framework. The Medical Device Regulation (MDR) emphasizes the importance of the collection of clinical and safety data after the introduction of the CE certification process and entry into the market. All medical devices carry safety and operational risk during their lifetime. These are due to a combination of features including product variability, environmental issues related to the use of the products and interactions of end users, such as unclear or misuse of the devices.
Post-market activity (PMS) in medical devices has been sensitive. A program to collect and report on malpractices, such as mechanical malfunctions and patient injuries, due to the return of device, repair, transfer and recall is important. However, due to the complexity of medical devices, the PMS system must be complex, so that earlier potential product failure issues can be identified.
“If you don’t design your own life plan, chances are you’ll fall into someone else’s plan. And guess what they have planned for you? Not much.”
Regulatory authorities began to look at the importance of PMS data and functional analysis, rather than relying on the impact of data collection on serious post markets event. To meet these requirements, developers need to be on their way considering the requirements for post-market inspection of medical and health equipment.
In particular product design and development, services are required to collect any residual risk before the product is delivered. However, it is important to collect and analyse the data during the process to ensure that the residual risk is acceptable. This will quickly identify the desired adverse effects and may indicate device improvement. Designed to help manufacturers with post-production research, ISO has released the ISO TR 20416:2020 medical devices. The company oversees manufacturing operations.
Pursuant to section 522 of the FDC act of 1990 (SMDA), the FDA has been authorized to order suppliers to conduct PMS for certain medical devices in part II and class III . These are:
- devices where failure will lead to serious adverse health complications
- devices which are implanted for one year in the body
- life-sustaining devices intended to used outside
- devices for use in pediatric populations
Examples are: pump infusion (II class); pacemakers (III class); and HIV testing (III class).There may be a need for FDA surveillance for 36 months or more, and developers must be legal to use it within 15 months of PMS.
ISO TR 20416: 2020 -An International Technical Report. Describe the active and systematic processes that manufacturers can use to collect and analyse relevant data. This will help you gain an overview of the PMS process. In addition, the procedures described are in accordance with applicable international standards, in particular ISO 13485 and ISO 14971. PMS is often associated with other processes established by the quality control system. The PMS process should be used to analyse the information available and to determine the safety and effectiveness of the product in accordance with the intended use.
This type of inspection meets the requirements of ISO TR 20416, which contains guidelines and methods that can be used to comply with relevant regulations. PMS is incorporated into life cycle management. A medical device can be identified as non-current, for example, by comparing it with other devices used for similar purposes, or by modifying or improving this concept from other medical procedures, or by developing devices from the market. PMS can lead to the generation of real data leading of new licenses for devices on the market. (New markets, new indicators to support the use of real equipment) or next-generation medical devices.
The EU Medical Device Directive (MDD) requires medical device manufacturers to conduct PMS at all times. Detailed post-market clinical follow up (PMCF) in the MEDDEV 2.12 / 2 sec 02 is required since January 2, 2012 For some devices that have a residual risk or require further identification of long-term therapeutic effects, e.g.
- innovative medical devices.
- device which has significant changes
- High risk associated with anatomical products or patient populations.
- risk level of disease
- Unanswered questions about safety and efficiency.
- Problems related to long-term safety results, effectiveness, adverse effects and surveillance data.
- Safety and efficiency information.
ISO TR 20416: 2020 can be used for developing best practices for PMS activities. Start by looking at the details and plan of the process. The latter affects the influence of business plans and objectives. This determines the type of information that needs to be stored. Goals can be associated with a variety of tools such as security, features, ease of use, programming, marketing, user feedback, and other opportunities for improvement.
The following information focuses on the role and application of data, the definition of the collection process, and the improvement of the data collection process. Data collection methods often include surveys, questionnaires, discussions, and post-marketing surveys.
ISO TR 20416 covers a variety of test procedures, depending on the type of raw material collected. Next is the data analysis. This includes evidence that the assessment achieved the targets set out in the postoperative plan and answered the identified questions.
- Identify relevant sources and predict the impact on product quality
- Suggesting a central security databases to ensure that data is collected, organized, and analysed before any signs of reaction occurs.
- guaranteed cooperation of all parties, including suppliers
- Open PMS support designed to identify technology issues
Many medical manufacturers struggle with the concept of working between safety and high performance or PMS expectations. BBMCT has the experience, insight, and tools to help companies identify what to do and find solutions that have a significant impact on the organization.