Standardizing the PMS
You have a medical device on the market and are subject to Post Market Surveillance (PMS), right? Well, how do you conduct PMS and is that the industry consent? Soon, these questions can be answered thanks to the new technical report ISO 20416.
Drafting ISO 20416, as in its current status as a draft in the ISO /TC210, will not add a new standard but instead a new technical report (TR). A technical report may include data obtained from a survey, for example, or from an informative report, or information of the perceived “state of the art”. With this, a TR is more of a report on best practices than on standardized procedures. However, a TR gives guidance to the industry for un-standardized procedures, such as the Post-Market Surveillance for Medical Devices.
What is ISO 20416 about?
ISO TR 20416 will not add new requirements nor copy them from the Medical Device Regulation (MDR 2017/745). Instead, the new technical report will give guidance on the interaction of ISO 14971 for Risk Management for Medical Devices, the MDR Annex I (Essential requirements) and the Post marketing and vigilance of medical devices. Therefore, the purpose of ISO TR 20416 is going to be to explain the purpose of PMS and evaluate the PMS system with a strong focus on the relationship of the different items in the standards and regulation.
Organizational processes affecting PMS
There are a bunch of organizational processes within a medical device company. These are, for example:
- Design and development process
- Risk management process
- Clinical evaluation process
- Regulatory affairs strategy and processes
- Marketing of medical devices
Even though these processes will not be addressed in the ISO 20416, the essential questions derived from these processes with impact on the PMS will be contained in the TR. To address and answer these essential questions, PMS data sources can be used, which might be:
- Published literature
- Post-Market Clinical Follow-up Studies
- Process and Product data
- Comparison product data
How to use PMS for decisions and actions
ISO TR 20416 defines essential questions to be answered via PMS data sources. But this is not all! With the guidance on the objectives of the PMS, the structured collection of PMS data and the analysis of the gathered data, a manufacturer of medical devices is given the tools to make informed decisions. Even though this is beyond the scope of ISO TR 20416, the tools and guidance how to come to the point at which decisions on actions can be made, are given.
Actions, based on PMS data and their analysis can be manifold and might include:
- Design change
- Review and potential revision of the risk management file
- Review and potential revision of clinical evaluation file
- Reporting of adverse events
- Submission for extended indications
In lieu of a standardized approach to PMS, ISO TR 20416 will give guidance to the manufacturers of medical devices on the objectives and purpose of PMS, potential data sources and data analysis in order to apply informed decision making on the safe and effective use of medical devices. The ISO TR 20416 is planned to be published by mid of 2020.